9090 Continuous Improvement Jobs - Page 40

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager, Global Regulatory Intelligence The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS - monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes producing regulatory intelligence outputs that enable timely and efficient product filings worldwide - for example, compiling summaries of country-specific regulatory requirements , analyzing recent or upcoming changes in regulations, and providing recommendations to teams on filing strategies that maximize speed and compliance. The Senior Manager is accountable for delivering these assigned intelligence outputs to a high standard of quality. Processes & Systems Ownership: Oversee the efficient operation of specific intelligence-gathering systems and processes . The Senior Manager may be responsible for maintaining and improving tools or databases used for monitoring regulations and for ensuring that intelligence monitoring, analysis, and communication processes run smoothly in their area of ownership. They work in partnership with colleagues across GRAAS to refine these systems and may evaluate opportunities for automation or outsourcing to improve efficiency. Regulatory Analysis & Strategy Input: Analyze regulatory trends across Amgen s global footprint, identifying differences and commonalities in submission requirements between regions or product types. Based on this analysis, recommend practical approaches to dossier content and preparation that will satisfy local requirements while enabling globally efficient submissions. The Senior Manager provides this strategic input to global and local regulatory teams to influence filing strategies and ensure alignment with intelligence insights. They also identify major impending regulatory changes and help plan for regulatory change management efforts across the business (providing input to any large regulatory change projects). Cross-Functional Collaboration: Develop trusted relationships with cross-functional colleagues - including Global and Local Regulatory Affairs teams, Regulatory CMC, Policy staff, and others - to integrate intelligence into regulatory strategy and decision-making. The Senior Manager engages GRAAS policy staff, product strategy leads, and other experts to help establish priorities for intelligence activities and to execute on agreed deliverables. They often lead or coordinate cross-product regulatory projects (such as analyses to support multiple product filings) under the direction of the RI Director. In doing so, they ensure that intelligence findings are translated into actionable strategies and that any recommendations for policy advocacy (to promote global harmonization of requirements, for example) are communicated to the relevant teams. Continuous Improvement: Engage in continuous improvement of Regulatory Intelligence processes. The Senior Manager monitors progress against intelligence workplans and objectives, and conducts regular reviews with the RI Director to report on outcomes. They propose and implement enhancements to tools, methodologies, and workflows to increase the effectiveness of intelligence gathering and dissemination. For instance, they might help refine how regulatory information is captured and shared, contribute to templating requirements for future automation projects, or update procedures in response to lessons learned. Knowledge & Skills: Regulatory Expertise: A strong foundation in regulatory affairs is required . The Senior Manager should have recent global filing experience and in-depth knowledge of regulatory agency guidelines and procedures across major and non-major markets. An understanding of local regulatory processes and how they impact global submissions is important. The role demands the ability to synthesize complex regulatory information (from disparate sources and regions) and distill it into clear, actionable insights and recommendations. Project Management & Communication: Excellent project management skills are needed to handle multiple intelligence projects and deliverables. The Senior Manager must be able to track tasks, meet deadlines, and coordinate input from various contributors. Strong presentation and interpersonal communication skills are essential in order to effectively communicate intelligence findings to stakeholders and to represent the intelligence function in cross-functional discussions. The ability to influence without direct authority (especially when recommending changes to regulatory strategy based on intelligence) is a key soft skill for this role. Technical and Process Skills: Preferred candidates will bring experience in systems management and process management , as the role involves working with databases/tools and improving processes for information gathering. Familiarity with knowledge management practices and change management principles is also beneficial - for example, knowing how to systematically capture regulatory knowledge and support teams through major regulatory changes. An innovative mindset toward leveraging technology (including potential use of AI tools for intelligence) is a plus, given Amgen s interest in future automation of submission-ready content. Qualifications: Basic Qualifications: A combination of advanced education and relevant experience in life sciences/regulatory affairs. For instance, a Doctorate degree in a related field with ~4+ years of experience, Master s degree with ~3+ years, Bachelor s degree with ~5+ years, Associate s degree with ~10 years, or even a high school diploma/GED with ~12 years of directly related experience could be considered acceptable minimums. (These ranges align with internal job level guidelines for a role at the Senior Manager level.) Preferred Experience: Relevant industry experience in biopharmaceutical regulatory affairs (especially in regulatory intelligence, policy, or strategy functions) is highly desirable. The ideal candidate will have a track record of successfully managing regulatory information or contributing to regulatory submissions across multiple regions. Experience working on cross-functional teams and exposure to regulatory policy development or external advocacy would be a plus for this role. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Career Category Information Systems Job Description Let s do this. Let s change the world. In this vital role you will work with product and platform teams in the implementation of 3DEXPERIENCE PLM solutions across the organization. They will interact with the organization s Product Teams (5 teams), Portfolio Management and Communities of Practice to continuously improve standards, processes, and automation enablers that accelerate staff and team SAFe maturity and overall business agility. This role will also facilitate the ongoing coordination across the program, enable and guide the scrum masters, and also act as a Scrum Master. This role requires deep understanding of Agile principles and frameworks like SAFe, Scrum practices, along with excellent leadership and communication skills. Roles & Responsibilities: Lead the implementation and adoption of the Scaled Agile Framework (SAFe) across the Product Teams. Assess current states of Agile maturity, identify areas for improvement, and guide the organization in aligning with SAFe principles and practices. Work closely with multi-functional teams to ensure alignment and effective communication. Facilitate collaboration between business and technical teams to achieve common goals. Communicate progress, challenges, and successes to customers at all levels. Collaborate with stakeholders to establish and track KPIs related to SAFe implementation. Support the Scaled Agile transformation efforts within the organization, including the adoption of SAFe principles, practices, and mindset. Assess the current state of Agile maturity and develop a roadmap for improvement. Provide guidance and support to teams and leaders in transitioning to Agile methodologies. Mentor Agile teams to improve their performance, collaboration, and delivery capabilities. Provide coaching to Scrum Masters, RTEs, Product Owners, and team members to enhance their Agile skills. Provide training and workshops on SAFe principles and practices to teams and collaborators. Foster a culture of continuous improvement and learning within the organization. Conduct regular assessments of current processes and identify areas for improvement. Implement standard methodologies and tools to streamline workflows and enhance productivity. Monitor and measure the effectiveness of process changes and make necessary adjustments. Act as a change agent, promoting the benefits of SAFe and driving organizational transformation. They collaborate with teams, leaders, and collaborators to create a shared understanding of SAFe and its value and help overcome resistance to change. Leverage agile tools such as Jira / Jira Align, Smartsheet s and Confluence Act as a change agent, promoting the benefits of SAFe and driving organizational transformation. Collaborate with teams, leaders, and collaborators to create a shared understanding of SAFe and its value and help overcome resistance to change. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of experience in SAFe implementations and delivery Preferred Qualifications: Functional Skills: Must-Have Skills: Strong knowledge of SAFe methodologies and practices Prior experience with Agile project management tools, such as Jira Software, Confluence, and Jira Align Hands on experience in guiding teams and Agile Release Trains through SAFe events and ensuring consistency to SAFe practices and behaviors Must demonstrate proactiveness in understanding the product team s backlog, dependencies, risks and influence the team to progress through sprints, product increments and releases. Must conduct PI planning event with the product team Excellent problem-solving skills and a passion for tackling complex challenges Collaborative spirit and effective communication skills to work seamlessly in a multi-functional team Good-to-Have Skills: Experiences with agile transformations in larger enterprises and legacy systems Jira Align experience Workshop facilitation and training development experience Knowledge of Product Lifecycle Management with software such as 3DEXPERIENCE, Windchill, Oracle Fusion Cloud or Teamcenter Professional Certifications: Certified SAFe Scrum Master, Release Train Engineer or equivalent Soft Skills: Excellent people and project management skills Ability to work collaboratively with cross-functional teams Ability to manage multiple priorities successfully High degree of initiative and self-motivation Team-oriented, with a focus on achieving team goals What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization. CRQ organization plays a critical role in ensuring that our research and development activities are conducted in an ethical and responsible manner . CRQ is responsible for ensuring that our research and development activities meet the highest standards of quality and compliance, ultimately keeping patients safe, protecting their welfare, while ensuring that all data produced has integrity. In this vital role , the Quality Compliance Senior Manager will contribute to providing leadership to ensure excellence in R&D Quality Processes is maintained through oversight and improvements when compliance issues are identified In addition, this role will serve as a mentor for Amgen staff in India who will be working to advance the Quality System, and they will act to manage day to day activities for the team. They will be an integral team member working globally with Business Process Owners to ensure compliance with regulations and other business requirements. This role will be part of supporting the digital quality management system (DQMS) as a Subject Matter Expert ( SME ) to support the core processes managed in Quality. Additionally, the Quality Compliance Senior Manager will provide proactive end to end quality support for the management of Quality Incidents/Quality Events , working closely with Quality Leads in approving investigations , including root cause analysis (RCA) and C orrective & Preventive Action (C APA ) plans. Roles & Responsibilities: The Quality Compliance Senior Manager will work both independently and in a team environment to foster collaborative relationships with in R&D Quality. In this vital role , they will be responsible for supporting processes and operational activities related to ; overseeing deviations, preparation of audits and inspections across R&D Quality including Good Pharmacovigilance Practice ( GPvP ), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). As part of strengthening and advancing Amgen s R&D QMS, this role provides end-to-end quality support to Deviation owners, RCA owners, and CAPA owners. Manages the Amgen India R&D Quality team to ensure that the team is supported and managed on a day-to-day basis. Support s the intake, triage, and categorization of deviations, ensuring appropriate classification and documentation. Facilitate s timely and thorough deviation investigations in collaboration with functional area r epresentatives and Quality Leads. E nsure s consistent and compliant documentation of deviation records within the electronic quality management system ( D QMS). Monitor s and ensure s adherence to timelines, escalating delays and risks as needed. Support s Global Patient Safety and Global Development teams in GxP inspection management activities and GxP audits from business partners Identif ies , lead s , or contribute s to continuous improvement initiatives to enhance CAPA management practices. Collaborate s with cross-functional partners to ensure processes remain effective, efficient, and aligned with industry best practices and evolving regulations. Ensure s the integrity, traceability, and quality of deviation and CAPA records in compliance with ALCOA+ principles. Monitor s quality metrics and key performance indicators (KPIs) related to deviation and CAPA management. Analyses trends and perform root cause trending to identify systemic issues and opportunities for process improvement. Manage s , organize s and analyse s data through different systems, tools, or platforms, including Excel and Smartsheet Maintain s knowledge of current regulatory and quality practices/issues Maintain s the Global R&D CRQ and SMQ SharePoint sites Manage s the appropriate archival and retention of audit documentation. Basic Quali fi cations and Experience: Master s degree with 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred Additional Competencies/Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Smartsheet, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx ) Good team building skills and the ability to on-board new employees and develop them over time Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP . Experience working in a multinational environment with global teams. Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure

Let s do this. Let s change the world. The Release Train Engineer is a leader and coach who facilitates team / ART / SRT events, processes, and supports teams in delivering value. The role involves facilitating communication and collaboration among Clinical Trial Execution Technology Product teams, enable and manage Agile Release Train, ensuring alignment with the program vision, managing risks and dependencies, and driving relentless improvement. They also often participate in the Lean-Agile transformation, coaching leaders, teams, and Scrum Master/Team Coaches in the new mindset and processes. They help adapt SAFe to the organization s needs, standardizing and documenting practices Roles & Responsibilities: Lead and manage product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools. Lead and facilitate agile events including stand-ups, sprint/PI planning, sprint/PI reviews, retrospectives, demos and backlog refinement meetings to promote team collaboration. Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Collaborate with multi-functional teams to identify business requirements and develop solutions that meet customer needs. Work with Product Owners, Product and Solution Management, and collaborators to ensure strategy and execution alignment Help the scrum teams achieve delivery acceleration focused on business outcomes by reaching higher levels of scrum maturity Identify, escalate, and manage risks and dependencies across ART to ensure that they are addressed in a timely manner Coordinate with Services and support to schedule resolution of issues with released products Foster a culture of continuous improvement within the ART Train by leading retrospectives and encouraging innovation Monitor and report on the progress of the ART, ensuring transparency and alignment with solution objectives Lead and facilitate the PI planning event and ensure strategic and organizational readiness, leadership team preparedness and logistics management for planning readiness Manage and optimize the flow of value through the Agile Release Train using various tools, such as Program Kanban and other information radiators Lead and facilitate agile events and events such as Program Increment (PI) planning, pre and post PI Planning, Solution demos, and iteration planning, to ensure alignment and collaboration across teams Provide guidance and support to RTEs, Scrum Masters, and Product Management teams to help them deliver value effectively and adhere to Agile standard methodologies What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 8 - 10 years of experience in Computer Science, Business, Engineering, IT or related field OR Bachelor s degree with 10 - 14 years of experience in Computer Science, Business, Engineering, IT or related field OR Diploma with 14 - 18 years of experience in Computer Science, Business, Engineering, IT or related field Strong understanding of Agile methodologies, particularly the Scaled Agile Framework (SAFe) Prior experience with Agile project management tools, such as Jira, Confluence and Jira Align Experience in guiding teams through Agile events and ensuring adherence to SAFe practices and behaviors Excellent problem-solving skills and a passion for tackling complex challenges with data Collaborative spirit and effective communication skills to work seamlessly in a multi-functional team Preferred Qualifications: Deep understanding of DevOps and Test Automation Processes in software delivery Workshop facilitation and training experience Professional Certifications : Certified SAFe Scrum Master or similar (preferred) Certified SAFe RTE or similar (preferred) Certified SAFe STE or similar (preferred) Soft Skills: Excellent people and project management skills Ability to work collaboratively with cross-functional teams Ability to manage multiple priorities successfully Team oriented with a focus on achieving team goals What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you will be part of the Global Patient Safety organization this team implements Intake and Triage of product complaints (PCs), adverse events (AEs) and other safety findings (OSFs). Their focus includes assuring compliant processes and systems remain fully compliant through the pharmacovigilance and quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Job Summary The PC Triage and Intake Associate is responsible for global triage of Product Complaints and ensure proper Adverse Events and/or Other Safety Findings were captured. Ensure to capture the patient outcome because of the reported event. This position ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes, and procedures. Key Activities Work within the Quality Management System framework including all applicable training and controlled documentation governing Pharmacovigilance processes. Triage of initial data entry (book-in) of new PC, AE and OSF cases is complete. Performs the initial book-in activities and appends additional information or documents to the case as they are received in the global intake system. Ensures compliance with global and local procedural documents and local implementation of Amgen Corporate, Patient Safety, and Quality objectives, policies, processes and procedures. Supports performance emphasized culture. Ensures quality of PC, AE and OSF records. Implements Standard Operating Procedure requirements for the triage process. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Education & Experience (Basic) Master s degree and 3 years of Drug Safety or Life Sciences experience OR Bachelor s degree and 5 years of Drug Safety or Life Sciences experience Education & Experience (Preferred) Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry Bachelor s Degree in a health-care subject area or scientific field Previous experience with a corporate intake system or safety database Ability to successfully manage workload to strict timelines Familiarity with basic project management tools Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable global regulatory requirements (Good Manufacturing Practices, Good Pharmacovigilance Practices) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The role is responsible for managing the R&D Veeva Vault Platform technical team that develops and implements technology strategies, solutions, and services to support Amgen s Veeva Vault Platform. The role will be involved in defining Amgen s Veeva Vault Platform strategy, guiding technology decisions, and ensuring that all implementations adhere to established architectural principles, Veeva s and the Industry s standard processes. The ideal candidate will have a consistent track record of leadership in technology-driven environments, managing technology platforms, digital transformation initiatives, and have a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. This role demands the ability to drive and deliver against key organizational critical initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Develop and maintain the enterprise Veeva Vault Platform architecture vision and strategy, ensuring alignment with business objectives Responsible for fostering platform reliability and efficiency through streamlined release management & execution and establishing consistent DevOps & CI/CD framework Accountable for designing and building customizations & configurations on the Platform as per the business needs including, creating custom objects, fields, workflows and SDKs Responsible for strategizing Platform Integrations while adhering to consistent integration standards and patterns, designing integration workflows, building connectors, centralizing build & run and performing consistent DevOps model for integrations Identify and mitigate architectural risks, ensuring that the platform is scalable, secure, and resilient Maintain comprehensive documentation of the platform architecture, including principles, standards, user guides, and models Drive continuous improvement in the architecture by finding opportunities for innovation and efficiency Work with partners to gather and analyze requirements, ensuring that solutions meet both business and technical needs Perform impact assessments, clearly define AS-IS and TO-BE states, and recommend platform upgrades in accordance with the new features and functionalities released by Veeva Design platform architecture that can scale to meet growing business needs and performance demands Develop and maintain logical, physical, and conceptual data models to support business needs Establish and enforce data standards, governance policies, and best practices What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications. Basic Qualifications: Master s degree with 4 - 6 years of experience in Computer Science, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Computer Science, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT or related field Must-Have Skills: Solid understanding of Veeva Vault Platform and Veeva Vaults 6-8 years Global Pharmaceutical experience Have Team\People management experience Experience with system integration technologies like Mulesoft, Databricks, etc. Excellent knowledge of data model and governance Solid understanding of pharmaceutical operations and data management business processes Experienced in pharmaceutical regulations and specifications Experienced in GxP process Experience working in agile methodology, including Product Teams and Product Development models Proficiency in designing scalable, secure, and cost-effective solutions Can work late hours Can work with multiple teams to meet the business and collaborator needs Can lead and guide multiple teams to meet business needs and goals Have collaborator and team management skills Good-to-Have Skills: Strong solution design and problem-solving skills Solid understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications: Veeva Vault Platform Administrator (mandatory) SAFe - DevOps Practitioner (mandatory) SAFe for teams (preferred) Soft Skills: Should be able convert business requirements into technical requirements Excellent critical-thinking and problem-solving skills Good communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. The role is responsible for leading and charting the course for the MuleSoft Platform team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a very hardworking team that is built for delivering high-end and innovative technologies. The ideal candidate will have a consistent record of leadership in technology-driven environments for the MuleSoft or Enterprise Integration area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with multi-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational pivotal initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle Develop and implement strategic plans for technology and workforce. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Understand the decision-making process, workflows, and business and information needs of business partners and team members Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an issue point and facilitating communication when service commitments are not met Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree/Masters degree/Bachelor s degree with 8- 13 years of experience in Computer Science, IT or related field. Functional Skills: Must-Have Skills: Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc. Good-to-Have Skills: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Exposure to or basic understanding of MuleSoft Anypoint Platform or similar integration tools Experience with Java, SQL Knowledge of cloud platforms (e.g., AWS, Azure) or container technologies (Docker) Professional Certifications (please mention if the certification is preferred or mandatory for the role): Scaled Agile Framework (SAFe) for Teams (preferred) Soft Skills: Excellent leadership and team management skills. Strong transformation and organizational change experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and solving skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. Manager Quality Complaints supervises a team of complaint investigators owning records with basic investigations, customer feedback records and records with limited information. Quality Manager Complaints ensures execution of the complaint process in compliance with company policies/procedures and regulatory requirements. Ensures execution of the quality complaint process in compliance with the applicable procedures, laws and regulations Ensures quality of tasks and complaint records Leads team initiatives/projects Establishes performance expectations and monitors for daily improvement Prioritizes workload as needed based on the changing incoming volumes or records Leads and mentors a team of complaint investigators, providing mentorship and support as needed Raises potential quality issues to management Monitors teams performance and oversight of staffs performance and development Assures training is continuously maintained Accountable for day-to-day operations of the staff members under their supervision Participates in audits and assessments as required, providing documentation and information on complaint management processes Develops a culture of continuous improvement and customer-centricity within the team What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master s degree and 4 to 6 years of quality management, with focus on complaints handling experience OR Bachelor s degree and 6 to 8 years of quality management, with focus on complaints handling experience OR Diploma and 10 to 12 years of quality management, with focus on complaints handling experience Preferred Qualifications: Quality and manufacturing experience in biotech, medical device or pharmaceutical industry Leadership skills and the ability to supervise multiple projects simultaneously Familiarity with advance project management tools Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience in driving decision making by using DAI principles Understanding of quality and industry requirements/expectations of a QMS Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Ability to negotiate a strategic position after taking feedback from multiple sources Proven ability to lead cross-functional teams, consistently deliver timely, and high-quality results Build rapport with customers and colleagues to develop a collaborative environment. Ability to handling disagreements and finding resolutions that satisfy both parties. Adjust strategies and approaches based on the specifics of each complaint. Ability to work optimally with global, virtual teams. Grasp reputability and steering through regulatory guidelines and compliance obligations. View issues from the customers perspective to better understand their concerns. Ability to travel +/- 20% of time to domestic and international Amgen sites Note: This role may require working in shifts or extended hours within the same shift What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The DevOps & Test Automation Lead manages Amgen s validated CI/CD tool-chain and automated quality framework for every Veeva Vault environment. Leading a global pod of DevOps engineers and test-automation specialists, you will design, operate, and continuously improve secure pipelines (Git Azure DevOps Vault CLI), build risk-based regression packs, and embed shift-left quality and compliance across all Vault releases. Your goal: faster, safer, fully auditable deployments that keep the business moving and regulators satisfied. Roles & Responsibilities: Plan, coordinate, and lead the execution of validation activities, including qualification and validation of Veeva Vault platform and applications. Develop, review, and approve validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Architect, version, and run the declarative CI/CD pipelines that package VPKs, promote them through DEV VAL PROD, and capture deployment evidence in Validation Manager. Develop and maintain API and UI suites; achieve 70 % automation for high-risk objects and lifecycles. Implement secrets vaults, static checks, and environment-as-code (Terraform modules) to harden security and speed rollbacks. Publish cycle-time, failure-rate, and defect-leakage dashboards; lead retrospectives and continuous-improvement sprints. Act as L3 owner for build or deployment failures; drive RCAs and preventive actions. Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Coach a distributed team of DevOps engineers and automation testers and upskill embedded functional testers on pipeline usage. Partner with Platform Strategy, Validation, and Integration leads to ensure standards, guard-rails, and automation patterns are consistently applied across all Vaults. Find opportunities for process improvements in validation activities. Know the latest on new technologies, validation trends, and industry standard processes to improve validation efficiencies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is someone with these qualifications. Basic Qualifications: Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of relevant experience Must-Have Skills Solid understanding of Veeva s Vault and its modules\applications Solid understanding of Test Automation techniques and tools. 6-8 year Global Pharmaceutical experience Proven ownership of enterprise CI/CD pipelines (Azure DevOps or GitHub Actions). Strong expertise in test-automation frameworks and integrating them into pipelines. Working knowledge of Vault CLI, VPK packaging, risk-based CSV requirements. Experience implementing secrets management and IaC (Terraform or equivalent) within regulated DevSecOps pipelines. Demonstrated ability to lead small, global technical teams and drive measurable KPI improvements. Experienced in GxP process Experience working in agile methodology, including Product Teams and Product Development models Proficiency in designing scalable, secure, and cost-effective solutions. Good-to-Have Skills: Knowledge of Veeva Vault Manager Exposure to containerized test grids (Docker-Selenium) or cloud test labs. ITIL Foundation and familiarity with ServiceNow change/incident modules. Strong solution design and problem-solving skills Solid understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Knowledge of Platform and Data Governance Professional Certifications Veeva Vault Platform Administrator (mandatory) SAFe - DevOps Practitioner (mandatory) SAFe for teams (preferred) Soft Skills: Data-driven problem solver; converts metrics into clear action plans and communicates effectively. Able to translate technical concepts for non-technical partners (QA, business owners). Resilient, inclusive leader who fosters teamwork across time-zones and cultures. Excellent critical-thinking and problem-solving skills Good communication and collaboration skills Demonstrated awareness of how to function in a team setting Demonstrated awareness of presentation skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The role is responsible for leading and charting the course for the Quality technology product (or services) team that builds and transforms technology capabilities that positively impacts business outcomes. This individual will be responsible for developing and leading a highly talented team that is built for delivering high-end and innovative technologies. The ideal candidate will have a proven track record of leadership in technology-driven environments for the Quality area and has a passion for fostering innovation and excellence in the biotechnology industry. Additionally, collaboration with cross-functional and global teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle and Quality processes, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational strategic initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Maintain strategic relationships and strong communication with the leadership team about IS services and service roadmaps to ensure that all the stakeholders feel informed and engaged Lead and manage large, diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US and other international locations. Oversee the software development lifecycle Develop and implement strategic plans for technology and workforce. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Attract and recruit top talent as part of an extensive Technology organization to be hired within India. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Responsible for managing, growing, and developing the Amgen Technology team in India, ensuring global ways of working are imbedded in the local organization Understand the decision-making process, workflows, and business and information needs of business partners and stakeholders Contribute and define business outcomes + requirements, technology solutions, and services Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as an escalation point and facilitating communication when service commitments are not met Ensure communication of key performance metrics and analysis of unmet needs Participate in stakeholder and other leadership meetings, working with other parts of the organization, and functional groups to ensure successful delivery Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services Facilitate best practice sharing, ensuring ongoing alignment with the Technology & Digital strategy Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance Ensure alignment of Technology service plans across organization Provide education to new partners with regards to IT service offerings Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate Degree OR Master s degree with 4 - 6 years of experience in Business, Engineering, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Business, Engineering, IT or related field Must-Have Skills: Knowledge of Pharma business processes and Global regulations. Experience with Veeva Platforms and/or Products Quality Suite Good Experience with GxP Validation processes Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation Experience in people management and leading matrixed teams, and passion for mentorship, culture and fostering the development of talent. Must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Exceptional collaboration, communication and interpersonal skills to effectively manage stakeholder relationships and build new partnerships. Experience in applying technology best practice methodologies: Scaled Agile (SAFe), ITIL, etc. Have strong business acumen. Can demonstrate deep understanding of industry, therapy and product Preferred Qualifications: Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytic/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business stakeholders Broad working knowledge of key IS domains and layers Professional Certifications: Veeva Vault Platform Administrator (preferred) Scaled Agile Framework (SAFe) for Teams Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Exceptional collaboration and communication skills. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented with a focus on achieving team goals. Strong presentation and public speaking skills. Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Equal opportunity statement Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. In this vital role, you will be responsible for planning, coordinating, and executing global labeling compliance activities to meet regulatory requirements across multiple regions. Working in close collaboration with cross-functional teams such as Regulatory Affairs, Quality, Clinical, Operations, and Supply Chain you will ensure that labeling processes, documentation, and systems remain accurate and inspection-ready. You will act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives and upholding high-quality standards. Key Responsibilities Global Labeling Coordinate end-to-end labeling changes (including updates, reviews, and approvals) ensuring alignment with regional and international regulations. Maintain and refine labeling templates, SOPs, and related documentation to sustain consistency and compliance. Cross-Functional Collaboration Collaborate with local, regional, and global teams including Regulatory Affairs, Quality, and Supply Chain to identify labeling requirements, address challenges, and meet project milestones. Communicate clearly and proactively with relevant stakeholders, providing expertise on labeling processes and compliance requirements. Planning & Execution Develop detailed project plans and timelines for labeling initiatives, ensuring completion within defined schedules. Monitor progress, identify potential risks, and implement corrective actions to keep projects on track. Process Improvement & Compliance Identify opportunities to streamline labeling workflows and enhance efficiency, driving continuous improvement within the labeling function. Support inspection readiness by maintaining up-to-date records, robust quality checks, and accurate documentation for audit purposes. Technical & Operational Support Perform critical reviews of artwork, translations, and labeling content to verify accuracy and adherence to regulatory standards. Troubleshoot issues related to labeling systems, ensuring timely resolution and minimal operational disruption. Mentoring & Knowledge Sharing Provide guidance and training to junior team members and new hires on labeling standards, tools, and best practices. Foster a culture of knowledge-sharing and continuous learning to build expertise within the team. Qualifications Basic Qualifications: Master s degree and 6 to 8 years of directly related experience OR Bachelor s degree and 8 to 10 years of directly related experience OR Diploma and 10 to 12 years of directly related experience Required Qualifications Knowledge of end-to-end labeling. Knowledge of Labeling Management Systems (e.g., Veeva Vault) and related document management tools. Strong knowledge of global regulatory labeling requirements, especially for pharmaceuticals or biologics. Proven track record in project planning and execution, with strong organizational and problem-solving skills. Excellent communication skills, with the ability to collaborate effectively in a global, cross-functional environment. Experience in continuous improvement methods to enhance labeling processes and efficiency. Soft Skills: Excellent written/oral communication skills and attention to detail Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment; Proficient time and project management skills. Self-starter with a drive and perseverance to achieve results. What we expect from you We are all different, yet we all use our unique contributions to serve patients. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The role will provide people leadership and project management expertise to the Biological Studies team that implements software platforms enabling the capture, analysis, storage, and report of in vitro assays and in vivo / pre-clinical studies, as well as those that manage compound inventories / biological sample banks. This individual will be responsible for developing and leading a very hardworking team that is built for delivering high-end and innovative technologies. As a scientific domain expert, this role will collaborate with cross-functional teams to identify strategies for implementation and adoption of standardized experimental data management platforms for drug discovery research. The ideal candidate will have a strong background in informatics solution delivery with a consistent record of leadership in technology-driven environments that facilitate R&D activities and has a passion for fostering innovation and excellence in the biotechnology industry. The candidate will have experience in evaluation and coaching of Technology Analysts, coupled with project management and budget management experience. Additionally, collaboration with global teams is required to ensure seamless integration and operational excellence. This role demands the ability to drive and deliver against key organizational critical initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead and manage diverse teams within a matrixed organization. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Manage, grow, and develop the Biological Studies Technology team in India, ensuring global ways of working are embedded in the local organization. Provide Project Management expertise for the implementation of specialized technology platforms that enable streamlined and automated scientific data management ensuring data integrity from lab to analytics. Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance. Provide technology delivery operations leadership for Biological Studies product teams that enable systems for in vitro, in vivo, preclinical, and clinical study data management. Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities. Foster a culture of collaboration, innovation, and continuous improvement. Understand the decision-making process, workflows, and business and information needs of business partners and team members. Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, facilitating communication when service commitments are not met. Ensure communication of key performance metrics and analysis of unmet needs. Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services. Collaborate with geographically dispersed teams, including those in the US, EU, and other international locations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 4 - 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor s degree with 6 - 8 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Functional Skills: Must-Have Skills: 5+ years of experience in implementing and supporting biopharma scientific software platforms. Expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Demonstrated excellence in technology delivery operations including project management and budget management Experience building strong teams with consistent practices in a matrix organization Preferred Qualifications: Experience in a people leadership role within a pharmaceutical or technology organization Experience leading the implementation of scientific software platforms such as Electronic Lab Notebook (ELN) and Laboratory Information Management Systems (LIMS) Budget management for technology ecosystem Experience in IS governance practices for product delivery and project management Knowledge of AI and machine learning for drug discovery research and preclinical development. Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Strong analytical/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Excellent leadership and team management skills Strong transformation and change management experience Exceptional collaboration and communication skills High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Ability to work effectively with global, virtual teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The Manager of Regulatory Promotions Operations supports the US Based Regulatory Promotions and Material Compliance team by leading the AIN based Associates and Sr Associates in providing seamless operations of critical Regulatory Promotions and Material Compliance (RPMC) services required for Amgen s USBO Region. RPMC services include the preparations of 2253 packages for US promotional content that will be sent to Submission Publishing for FDA submission, Pre-Clearence Submission content preparation, US Label Update Commercial Process, Digital Asset Management Archiving of Global promotional content, Global Digital Site Registry Audit Requests. The role will work closely with US based RPMC Business Process Owners on meeting the timelines tied to the USBO business calendar (E.G. Product Launches, New Indications, etc.). Roles & Responsibilities: Manages 10 Staff of Associates and Sr. Associates responsible for the core services Preform staff mid-term and annual performance review and annual goal setting Manges staff performance Ensure business continuity by managing the onboarding and offboarding processes for transitioning staff Oversee staff resource allocation and assignments and ensures that all Service Level Agreements (SLAs) are meeting or exceeding their targets Responsible for annual workforce planning based on expected USBO demand Ensures process consistency across all services provided Trains staff on new procedures and system functions as they are rolled out across the RPMC department Provide Project Management support to key initiatives or continuous improvement projects. Collaborate with leaders to identify skill gaps and performance improvement opportunities Establish a vision for fostering a culture of continuous learning and development Required Knowledge and Skills: Deep experience in leading Coaching, Mentoring and Counseling Ability to be flexible and manage change Regulatory requirements Scheduling Project Management Change Management Problem solving Excellent written/oral communication skills and attention to detail Must demonstrate strong leadership skills in a team environment which requires negotiation, persuasion, collaboration, and compliance judgment Proven experience with Veeva PromoMats system including the Proven experience in leading a team with multi service operations with the ability to step in an help their team when needed. Preferred Knowledge and Skills: Deep understanding of Pharmaceutical promotional Medical, Legal, Regulatory (MLR) review process and compliance requirements Strong skill in the use of the Veeva PromoMats System Deep understanding of good compliance practices Basic Education and Experience: Master s degree and 4 years of related experience OR Bachelor s degree and 6 years of related experience OR Associate s degree and 10 years of related experience Preferred Education and Experience: Bachelor or Mater Degree with the relevant experience Experience working in a Regulatory Promotions of Marketing Operations organization AIN working hours for this position: This position supports the Regulatory Promotion and Material Compliance activities serving Amgen s US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.

Let s do this. Let s change the world. In this vital role you will lead and coach who facilitates team events, processes, and supports teams in delivering value within the Hire to Retire capability. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, managing risks and dependencies, and driving relentless improvement. They also often participate in the Lean-Agile transformation, coaching leaders, teams, and Scrum Master/Team Coaches in the new mindset and processes. They help adapt SAFe to the organization s needs, standardizing and documenting practices. Roles & Responsibilities: Lead and manage product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools. Lead and facilitate agile events including stand-ups, sprint/PI planning, sprint/PI reviews, retrospectives, demos and backlog refinement meetings to promote team collaboration. Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Collaborate with cross-functional teams to identify business requirements and develop solutions that meet customer needs. Work with Product Owners, Product and Solution Management, and collaborators to ensure strategy and execution alignment Help the scrum teams achieve delivery acceleration focused on business outcomes by reaching higher levels of scrum maturity Identify, escalate, and manage risks and dependencies across Teams to ensure that they are addressed in a timely manner Coordinate with Services and support to schedule resolution of issues with released products Foster a culture of continuous improvement within the Teams by leading retrospectives and encouraging innovation Monitor and report on the progress of the Team, ensuring transparency and alignment with solution objectives What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with 4 - 6 years of experience in Computer Science, Business, Engineering, IT or related field OR Bachelor s degree with 6 - 8 years of experience in Computer Science, Business, Engineering, IT or related field OR Diploma with 10 - 12 years of experience in Computer Science, Business, Engineering, IT or related field Strong understanding of Agile methodologies, particularly the Scaled Agile Framework (SAFe) Prior experience with Agile project management tools, such as Jira, Confluence and Jira Align Experience in guiding teams through Agile events and ensuring adherence to SAFe practices and behaviors Excellent problem-solving skills and a passion for tackling complex challenges with data Collaborative spirit and effective communication skills to work seamlessly in a cross-functional team Preferred Qualifications: Deep understanding of DevOps and Test Automation Processes in software delivery Workshop facilitation and training experience Certified SAFe Scrum Master or similar (preferred) Experience working within the Hire to Retire or Human Resources function Soft Skills: Excellent people and project management skills Ability to work collaboratively with cross-functional teams Ability to manage multiple priorities successfully Team oriented with a focus on achieving team goals What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The Scrum Master is a leader and coach who facilitates Scrum events and processes, delivering value for the Global Quality Control product team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, managing risks and dependencies, and driving relentless improvement. The Scrum master helps adapt SAFe to the organization s needs, standardizing and documenting practices. The role requires a solid background in the end-to-end software development lifecycle and a Scaled Agile practitioner, coupled with leadership and transformation experience. Roles & Responsibilities: Lead and manage product delivery using agile frameworks and techniques. Align with Agile values, such as prioritizing individuals and interactions over processes and tools. Ensure day-to-day operations by automating tasks, monitoring system health, and minimizing downtime through incident response Capture the voice of the customer to define business processes and product needs Collaborate with Global Quality business collaborators, architects, and engineering teams to prioritize release scopes and refine the product backlog Lead and facilitate breakdown of Epics into Features and sprint-sized user stories and participate in backlog reviews with the development team Clearly express features in user stories/requirements so all team members and collaborators understand how they fit into the product backlog Ensure Acceptance Criteria and Definition of Done are well-defined Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators Help develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, requirement validation, and user acceptance Develop & maintain documentation of configurations, processes, changes, communication plans and training plans for end users Collaborate with geographically dispersed teams, including those in the US and other international locations Foster a culture of collaboration, innovation, and continuous improvement Leverage agile tools such as Jira / Jira Align, Smartsheet s and Confluence What we expect of you Must-Have Skills: Solid understanding of Agile methodologies, particularly the Scaled Agile Framework (SAFe) Prior experience with Agile project management tools, such as Jira, Confluence and Jira Align Experience in guiding teams through Agile events and ensuring consistency to SAFe practices and behaviors Good-to-Have Skills: Experience in managing product features for PI planning and developing product roadmaps and user journeys Experience maintaining SaaS (software as a system) solutions and COTS (Commercial off the shelf) solutions Technical thought leadership Able to communicate technical or complex subject matters in business terms Familiarity with GxP computer system validation Experience with Project planning/Data modelling tools such as Smartsheet, Lucid, Miro, etc. Familiarity with Quality Control platforms and Processes (LIMS, ELN, Empower) Basic Qualifications and Experience: Master s degree with 4 - 6 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Bachelor s degree with 6 - 8 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies OR Diploma with 10 - 12 years of experience in Computer Science/Information Systems experience with Agile Software Development methodologies Professional Certifications Certified SAFe Scrum Master or similar (preferred) ITIL (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. EQUAL OPPORTUNITY STATEMENT .

The External Workforce Sr. Manager is responsible for supporting the management and coordination of the organizations external workforce in partnership with our Master Service Providers (MSP), including contingent workers, independent contractors, vendors, and service providers. This role will lead the planning, governance, and operational management of our external workforce to ensure the efficient use of labor categories and other external resources across the organization while maintaining compliance, optimizing cost, and enhancing workforce agility. This role works cross-functionally with HR, Procurement, Legal, IT, and department heads to ensure cost-effective and compliant use of external talent. As a critical member of our external workforce team, you will help ensure the organization can scale flexibly and compliantly, while meeting the specialized talent needs of a fast-paced and regulated biotech environment. Key Responsibilities: Strategy & Governance Develop and implement an enterprise-wide external workforce strategy aligned with scientific, clinical, and operational goals. Establish and maintain governance frameworks, policies, and compliance standards in partnership with Legal, HR, Procurement, and department leaders. Program & Vendor Management Oversee the full lifecycle of the external workforce including sourcing, onboarding, tracking, and offboarding via VMS such as SAP Fieldglass. Manage key vendor relationships (CROs, staffing firms, consultants), ensuring high performance and cost-effectiveness. Partner with regional and functional leads on continuous improvement initiatives. Risk & Compliance Ensure adherence to labor laws, co-employment risks, GxP, and FDA/EMA requirements. Serve as process owner for SOX audits, including execution of monthly controls and support for audit readiness. Technology & Analytics Lead development of dashboards and reporting tools (e.g., Tableau, Alteryx) to monitor cost, utilization, and workforce trends. Provide insights and recommendations to senior leadership to inform strategic workforce planning. Stakeholder Engagement & Team Leadership Act as a trusted advisor to business leaders across various functions. Mentor and manage a team (where applicable), and champion process standardization, scalability, and operational excellence. Support change management, training, and policy adherence across the organization. Win - What We Expect of You Bachelor s degree in Human Resources, Business, Life Sciences, or related field (MBA or MS preferred). 8-12 years of experience managing external workforce programs, with 3+ years in life sciences or biotech preferred. Deep expertise in contingent workforce models and VMS tools (Fieldglass, Beeline). Strong knowledge of regulatory and compliance frameworks (e.g., SOX, GxP, FDA). Proven success leading cross-functional programs and influencing senior stakeholders. Thrive - What You Can Expect from Us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. We offer competitive annual base salary, and a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. .

Let s do this. Let s change the world. We are seeking a strategic and execution-focused GV&A Amgen India Leader to play a critical leadership role in the growth and evolution of our Innovation Center. In this vital role you will be responsible for building new functional capabilities, transitioning existing work, and insourcing work from external vendors to drive operational excellence, cost efficiency, and innovation. This role is part of the Global HEOR Leadership Team. Lead Capability Design and Stand-Up Define and execute a phased roadmap to establish new functional capabilities within the innovation center across Value & Access or other relevant business areas. Partner with global functional leaders to assess current state operations, identify transition candidates, and co-design future-state workflows. Manage Work Transition and Insourcing Develop and oversee transition plans to migrate work from internal global teams to the innovation center with minimal disruption. Lead the insourcing of services currently delivered by external vendors, ensuring appropriate knowledge transfer, risk mitigation, and operational readiness. Build and Develop High-Performing Teams Hire, onboard, and develop talent required to deliver on newly created capabilities. Instill a culture of collaboration, continuous improvement, and accountability within the innovation center team. Drive Cross-Functional Engagement and Alignment Act as a key liaison between the innovation center and business units globally, ensuring alignment on goals, processes, and success measures. Facilitate stakeholder alignment across regions and functions to support smooth transitions and integration of new ways of working. Monitor Progress and Optimize Delivery Track key performance metrics and transformation milestones, regularly reporting progress to senior leadership. Identify and resolve roadblocks, process gaps, and resourcing needs as part of continuous improvement efforts. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The ideal candidate will be a skilled change agent with deep experience in Value and Access as well as HEOR, organizational transformation, capability development, and cross-functional collaboration. This role offers the opportunity to help shape the future operating model of a high-impact global organization. Basic Qualifications & Experience: Doctorate degree in Business, Operations, Health Economics or Life Sciences and 4 years of experience as V&A leader, having worked across HEOR, pricing and access strategy, either in life sciences or consulting OR, Master s degree in Business, Operations, Health Economics or Life Sciences and 14 to 16 years of experience as V&A leader, having worked across HEOR, pricing and access strategy, either in life sciences or consulting OR, Bachelor s degree in Business, Operations, Health Economics or Life Sciences and 16 to 18 years of experience as V&A leader, having worked across HEOR, pricing and access strategy, either in life sciences or consulting. Proven experience in standing up new teams, managing, and retaining talent in India Demonstrated success in managing complex transitions, including work insourcing and internal capability shifts. Strong leadership, stakeholder management, and communication skills. Ability to thrive in a fast-paced, ambiguous environment and drive clarity through structured problem-solving. Excellent English oral and written communication Comfortable working in a global team across time zones and cultures. Preferred Experience Prior experience working in or with a global innovation or shared services center. Knowledge of change management principles and tools (e.g. Prosci, ADKAR). What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. The Associate User Experience Designer balances user goals, business requirements, and technical feasibility to deliver simple and elegant designs as part of a product team. The designer work closely with cross-functional teams to create intuitive, user-friendly interfaces. They will utilize user research, data analysis, and feedback to iterate and improve designs continuously. They will collaborate with collaborators and product teams to ensure the designs are feasible, considering best practices, usability, and accessibility standards. Clear communication, comfort in ambiguity, and agility in adapting to business needs are crucial attributes for success in this role. Roles & Responsibilities: Engage in design discussions with product managers and business leads to define user requirements and design goals. Collaborate with developers to create and implement design solutions that are technically feasibility while ensuring an optimal user experience. Create annotated prototypes and/or wireframes of user interface designs that visually and textually communicate the intended behavior of a software application. Apply Figma for creating wireframes, prototypes, and visual designs. Ability to use a design system and design components in Figma. Ability to use JIRA for tracking design tasks, regularly updating status, and handling workflows. Proactive problem solving and engagement to meet timelines and objectives Maintain a user-centered design approach and ensure all designs are simple, elegant, intuitive and follow standard methodologies and accessibility guidelines. Communicate design ideas and prototypes clearly to key customers and team members. Stay updated with the latest design trends, techniques, and AI developments to ensure the best user experience. Engage in design critiques by sharing designs and giving feedback to teammates. Foster a collaborative team mentality where everyone feels comfortable sharing ideas and constructive criticism, ensuring that the teams collective creativity and expertise drive continuous improvement. Adapt to a fast-paced environment and learn new tools and methods quickly. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Bachelor s degree and 0 to 3 years of experience in design or related field OR Diploma and 4 to 7 years of experience in design or related field Must-Have Skills: Proficient in using standard design & wireframing tools (Figma) hand drawing, whiteboarding, and visual communication, time-based and interactive prototyping tools (Figma Prototyping, Miro). Knowledge in building responsive desktop, web and mobile applications. Knowledge of UI/UX best practices, accessibility standards, and design patterns. Knowledge utilizing a design system in Figma to create designs. Engagement in design workshops with product team and ability to clearly articulate design decisions. Ability to update designs based on feedback from workshops with collaborators. Ability to communicate designs and ideas through communications tools such as Figma comments. Note: A link to a design portfolio is required for consideration for this role. Please include a link in your resume, along with any required passwords to view design work if necessary. Preferred Qualifications: Good-to-Have Skills: Knowledge of HMTL, CSS, Javascript to determine feasibility of designs Experience with SAFe Agile processes Familiarity with Figma design systems and how to use components within Figma. Passionate about team engagement Passionate about learning new technologies, new methods, and new skills. Have a good understanding of Agile teams, practices, and principles. Knowledge of data visualization and visual communication standard methodologies. Ability to see the bigger picture, planning for both immediate and incremental releases within a 2-week sprint cadence. Professional Certifications: Any user experiences design certification (optional) Agile related certification (optional) Soft Skills: Strong verbal written communication skills. Excellent analytical troubleshooting skills. Strong presentation and public speaking skills Proactive problem-solving skills. Timely attendance and participation in team meetings and SCRUM ceremonies. Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you will own and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement. The Associate conducts complaint investigation tasks related to customer feedback records and records with limited information available, as well as records that might not require any investigation. The Associate also determines if complaint investigations require critical issue for further higher level investigation. Evaluates and ensures triaged product complaint records stay in sync with applicable procedures Evaluates and manages customer feedback records to closure Evaluates records that have been determined to be voided and completes the void process Owns records with limited information Completes assigned assessments per applicable procedures Ensures quality of complaint records Drives the complaint process per SOP requirements Owns or handles the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Bachelor s degree and 0 to 3 years of Data Sciences, Biochemistry, Chemical Engineering or other Sciences experience OR Diploma and 4 to 7 years of Data Sciences, Biochemistry, Chemical Engineering or other Sciences experience Preferred Qualifications: Basic to Intermediate understanding of other tools (e.g. Smartsheet, Veeva) to support the development and management of documents, business/system processes and related data. Knowledge of Microsoft copilot, open AI Chat GPT, and other AI/Large Language Model (LLM) tools. Understanding of key regulations (e.g. EMA, FDA) and ethical guidelines (GxP) governing the Pharmaceutical industry Accurate utilization of process management systems (eg Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials; creation & distribution of status reports Experience in at least one of the following areas: Quality Management, Document Management, Quality Assurance, Learning Management / Learning Management Systems (LMS) Practical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel, Visio) Practical experience with handling projects / multiple projects at the same time Verbal and written communication skills/writing skills Process/business writing skills Technical Learning Skills - ability and willingness to learn new technologies, processes, and methodologies. Active listening skills Critical / problem-solving / logical thinking skills and process oriented Ability to understand and follow processes / process instructions Attention to detail Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Finance Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Amgen is seeking an Accounts Payable (AP) Senior Associate who will be part of Amgen s Global Procure to Pay (P2P) organization. This individual will be responsible for supporting the invoice exception process and will be critical to drive customer satisfaction across Amgen business units through optimum utilization of resources and continuous improvement. The role will be located in Hyderabad, India. Specific responsibilities include, but are not limited to the following: Serves as a Tier 2 escalation point for BPO resources. Responsible for the AP exception handling process and related customer support. Accountable for driving customer satisfaction through timely and accurate resolution of exceptions. Ability to work in a global matrix environment that is fast paced with shifting priorities. Ability to work proficiently in SAP and Excel. Work with team to continually update and improve the customer helpdesk and exception management playbooks in accordance with the other service owners and process owners. Support decisions related to customer helpdesk and AP exception escalations. Conduct regular assessments of helpdesk tickets and AP exceptions to derive root causes and propose solutions to continuously improve performance against SLAs. Ensure compliance to internal and external policies, regulations, and laws applicable to the function. Basic Qualifications Master s degree OR Bachelor s degree and 5 years of directly related experience OR Associate s degree and 7 years of directly related experience OR High school diploma / GED and 10 years of directly related experience Preferred Qualifications Degree in Finance, Accounting or closely related field 3+ years experience in Procure to Pay customer support / AP exception handling. Experience with ERP systems (SAP) Strong attention to detail, verbal communication, and interpersonal skills. Strong customer service focus while having a problem-solving attitude. Ability to multi-task and work within tight timelines. Take ownership of assigned activities. Be a team player. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The Scaled Agile Coach is a strong technical role that works within teams across the organization to identify and develop process improvements and enablers that accelerates the Agile maturity and value delivery of Biotechnology Product and Platform teams. This role combines SAFe coaching with strong business analysis skills to drive adoption and implementation of Agile methodologies. The Coach is a member of the SAFe Enablement team that continuously improves standards, processes and automation enablers, drives a culture of continuous innovation across the enterprise, and enables effective Agile Release Trains, Solution Trains and Portfolio. Roles & Responsibilities: Support the SAFe Agile transformation efforts within the organization, including the adoption of SAFe Agile principles, practices, and mindset. Assess the current state of Agile maturity and develop a roadmap for improvement. Provide guidance and support to teams and leaders in transitioning to Agile methodologies. Advise SAFe events, including PI Planning, Scrum of Scrums, and Inspect & Adapt workshops. Mentor Agile teams to improve their performance, collaboration, and delivery capabilities. Provide coaching to Scrum Masters, RTEs, Product Owners, and team members to enhance their Agile skills. Collaborate with key partners to gather and analyze business needs and requirements. Identify process improvements and enablers to enhance team performance and efficiency. Conduct regular assessments of current processes and identify areas for improvement. Implement standard methodologies and tools to streamline workflows and enhance productivity. Monitor and measure the effectiveness of process changes and make necessary adjustments. Provide training and workshops on SAFe principles and practices to teams and key partners. Foster a culture of continuous improvement and learning within the organization. Work closely with cross-functional teams to ensure alignment and effective communication. Facilitate collaboration between business and technical teams to achieve common goals. Communicate progress, challenges, and successes to stakeholders at all levels. Identify and remove impediments that hinder Agile adoption and team productivity. Promote a culture of continuous improvement by encouraging teams to experiment, learn, and adapt their processes. Implement metrics and KPIs to track the effectiveness of Agile practices and make data-driven recommendations for improvement. Identifying Value Streams and the Agile Release Train. Creating the implementation plan. Coaching ART execution Build and nurture an internal Agile community of practice to share knowledge, experiences, and standard methodologies. Stay up to date with industry trends and emerging Agile practices and introduce innovative ideas to the organization. Leverage agile tools such as Jira / Jira Align, Smartsheet s and Confluence Train executives, managers, and leaders on the SAFe framework, socializing the new concepts and providing orientation and overview training. Win What we expect of you Basic Qualifications: Deep knowledge and expertise in SAFe. Combine technical knowledge of SAFe with a motivation to improve software, systems, and Agile business processes Proficiency in Jira, Confluence, and other agile tools SAFe training experience Preferred Qualifications: Workshop facilitation experience Experience with other agile methodologies (Scrum, Kanban) Familiarity with Lean principles and practices Advanced certifications in business analysis (CBAP, PMI-PBA) Education and Professional Certifications Master s degree and 4 to 6 years of experience with SAFe, software, systems, and Agile business processes OR Bachelor s degree and 6 to 8 years of experience with SAFe, software, systems, and Agile business processes OR Diploma and 10 to 12 years of experience with SAFe, software, systems, and Agile business processes OR SAFe for Teams certification or equivalent - mandatory Soft Skills: Excellent analytical and gap/fit assessment skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills. Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Summary As a key resource within the Audit Management Office (AMO), this role ensures effective coordination and management of audits and inspections involving Data, Digital & IT (DD&IT) systems and processes. This includes supporting GxP audits (e. g. , GMP, GCP) and regulatory inspections by authorities such as FDA, EMA, MHRA and Swissmedic. The associate acts as a liaison, ensuring that relevant DD&IT subject matter experts address audit queries and deliver required documentation in a timely and accurate manner. Additionally, the role involves monitoring audit findings, overseeing remediations, and driving continuous improvement in audit readiness. About the Role MAJOR ACCOUNTABILITIES Govern processes to effectively manage both internal and external audits across Data, Digital & IT (DD&IT), focusing on GxP (e. g. , GMP, GCP), quality, and regulatory-related audits, along with stakeholder management, remediation tracking, status reporting, and lessons-learned sharing. Act as the single point of contact (SPOC) for audit teams across DD&IT, coordinating audit and inspection activities, ensuring effective communication, and maintaining compliance throughout the process. Notify and mobilize relevant DD&IT stakeholders such as application managers, system owners, QA, Information Security & Compliance (ISC), and SOP process owners for audits and inspections, ensuring timely readiness. Coordinate globally with business teams to ensure audit support tickets are created, tracked, and resolved in alignment with Novartis policies and procedures. Conduct pre-audit meetings to clarify IT scope, agree on auditor pre-requests, align timelines, and ensure stakeholders understand expectations for audits and inspections. Provide advice and guidance to DD&IT teams on GxP and information systems compliance requirements to ensure alignment with regulatory standards such as FDA, EMA, MHRA and Swissmedic expectations. Track and proactively manage audit requests across different time zones, ensuring SMEs respond on time, identifying backups where needed, and escalating delays or deviations as appropriate. Guide DD&IT SMEs by clarifying audit process requirements and supporting them throughout the audit lifecycle, ensuring accurate delivery of requested information. Conduct training sessions on audit readiness, including proper inspection etiquette and effective collaboration during audits and inspections. Collaborate with internal teams to improve and standardize governance frameworks and processes, aiming to reduce audit findings and improve inspection readiness. Escalate compliance deviations and critical quality issues to senior management and coordinate resolution efforts, ensuring corrective and preventive actions (CAPAs) are implemented effectively. Manage relationships at a global level across divisions and functions, including ISC, e-Compliance, and DDIT teams, facilitating cross-functional alignment and collaboration on audit-related matters. Coordinate and participate in audit closing meetings, preparing summaries of findings, tracking observations, and supporting SMEs in addressing them. Partner with security, compliance, and quality experts to identify focus areas, evaluate industry trends, and recommend strategies to improve audit processes and outcomes. Monitor and report on audit findings, remediation actions, and related improvement activities, ensuring compliance, security, and quality gaps are addressed thoroughly. Drive and coordinate key Sarbanes-Oxley (SOX) activities in collaboration with application teams and external auditors, ensuring alignment to SOX IT controls and timely delivery of evidence while minimizing audit-related disruptions. Ensure adherence to security and compliance policies and procedures within the audit management governance framework, while aligning with internal and external quality standards. Minimum Requirements University degree or equivalent. Master s degree in IT, Quality Management, Business Administration, or related fields. Overall 8-10 years of work experience in quality management, audit, and compliance within IT, preferably in a global organization. Experience in the pharmaceutical industry or other regulated industries, with knowledge of GxP processes and compliance requirements. In-depth understanding of pharma business processes and their interrelationship with IT systems and regulatory frameworks. Proven track record of managing audits, regulatory inspections, and remediation efforts in pharma or other highly regulated environments. Experince with Computer System Validation (CSV), system testing, and adherence to lifecycle validation processes (e. g. , requirements gathering, system design, validation testing, implementation, and maintenance). Knowledge of ITIL processes and best practices. Demonstrated ability to work effectively in large, cross-functional, global organizations. Proficient in Excel, PowerPoint, and other productivity tools for reporting and presentation. Business-proficient in English (written and spoken). Strong communication skills with the ability to articulate expectations and audit requirements clearly to diverse teams and stakeholders. Ability to manage multiple priorities and time-sensitive processes efficiently. ITIL-certified professional. Strong knowledge of validation practices, including GxP, Sarbanes-Oxley (SOX), and pharmaceutical quality compliance standards. understanding of CSV lifecycle processes, including risk assessment, traceability matrix development, protocol execution, and impact analysis. Business knowledge or experience in IT s role supporting audit and compliance functions within regulated industries. Expertise in Computer System Validation (CSV) testing methodologies and frameworks. ? Our purpose is to reimagine medicine to improve and extend people s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www. novartis. com / about / strategy / people-and-culture Commitment to Diversity and Inclusion: Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Summary The Global Change Control Manager oversees the entire process of managing GxP-impacting changes within the global manufacturing network. This role is responsible for the change control process from initiation, through impact assessment, planning, execution tracking, documentation, CAPA effectiveness, continuous improvement in change governance, and metrics reporting. The manager works closely with cross-functional teams such as Regulatory, Quality, Operations, to support timely implementation, risk management, and ongoing improvement in change governance. The role also contributes to audits, inspections as well. About the Role Key Responsibilities: Good Understanding of Global Change control process and able to advice on Global and Local Change request strategy. Align between sites and Regulatory team regarding Change control plan, impact / implementation on sites. Prepare the change request plans and present them for endorsement at the Change review board (CRB) Open global change requests, assign impact assessment actions, and manage the lifecycle of Change Requests (CR). Track and report the implementation status of change requests with cross-functional teams. Manage and maintain change control documentation, including updates, version control, and compliance with cGMP and regulatory standards. Facilitate change control review meetings, capturing key information and translating it into actionable and clear documentation. Provide support during audits and inspections by ensuring accurate and readily available change control documentation. Collaborate with cross-functional teams (Quality, Operations, Engineering) for accurate documentation. Track and report metrics related to documentation timeliness, compliance, and quality. Comply with internal processes like KPI reporting, ticket management, and functional requirements. Contribute to process improvement initiatives by identifying and addressing gaps in change control documentation workflows. Support and contribute to quality management system (QMS) actions such as Change Controls, CAPA, effectiveness checks (EC), risk assessments, and OOXs management. Participate in periodic QMS reviews to identify and contribute to areas of improvement where applicable. Good Understanding of Process/Cleaning Validation and Technology transfer concepts and requirements including transfer protocols, validation protocols & reporting and comparability reports Collaborate with site teams for Transport Validation / Shipping verification activities including validation risk assessment, testing protocols and reports. Act as SPOC to drive key Global projects within the platform and collaborate with sites to ensure timely execution of tasks/ deliverables Desirable Requirements: Bachelors/Master degree in Pharmacy, Pharmaceutical Technology, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience. Good understanding of Radio Ligand Therapies (RLT) platform Minimum 10 years of experience in MS&T, Quality Assurance in Manufacturing of Biologics Drug substance and Drug Product. Hands on experience in 1-QEM tool. Strong understanding of Global change control processes, cGMP, and regulatory requirements Proven project management experience in a cross-functional environment (e. g. multi-site, technical development, other functions). PMP is added advantage. Expertise in document management system and writing technical reports Experience in Health authority audits and Self inspections. Good communication, presentation and Interpersonal skills. Proficiency in English (oral and written) is mandatory. Essential Requirements: Quality / Accuracy / Right First Time Quality System Management (Change Control, CAPA, Risk Assessment and EC) Support Accuracy and compliance of change control documentation Timeliness of documentation updates and approvals Stakeholder satisfaction with documentation quality and usability Adherence to regulatory requirements during audits and inspections Effectiveness of standardized documentation processes Skills: Change Control Process Effective communicator Strong cross functional collaboration Biologics Manufacturing Process Project Management Good Documentation Practice Effective stakeholder engagement Report writing Knowledge Of GMP (Good Manufacturing Practices) Deviation management Corrective and preventive action (CAPA) General HSE Knowledge Manufacturing (Production) Manufacturing Technologies. Process And Cleaning Validation Why Novartis: Commitment to Diversity and Inclusion: . Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Summary -To act as a trusted advisor offering in-country policy expertise and knowledge to support and educate leaders, managers and associates on all P&O topics on the moments that matter. -People Partners support all divisional customer groups in country enabling the delivery of lifecycle events, the employee value proposition, talent acquisition, talent management, learning, performance management, employee relations, rewards, pay and reporting. In addition, People Partners implement P&O change initiatives at a country level acting as detailed designers and agents of change by working with Business Partners. -The People Partner lead in small countries acts as a single point of contact within country to align on people partner related issues, above country topics and coordination of country team members. About the Role Major accountabilities: Partnering and coaching managers and associates on People related Processes and moments that matter. Drives P&O initiatives, supporting the overall P&O strategy -Activate business ownership and accountability of diversity, equity and inclusion initiatives -Advise on and handle diversity, equity and inclusion at all levels, e. g. , gender representation, LGBTI, pay equity -Champions culture and supports implementation of corporate initiatives (e. g. Evolve, Hybrid working) -Coaches and guides people managers on role evaluations in line with local governance. Communicate full spectrum of inclusion & Psychological Safety -Design new hire onboarding initiatives. Drive buy-in and utilization of data and analytics to identify risk and trends, and to apply these business insights to inform decisions and actions. Drive D&I efforts and align with global or local initiatives / implementation. Drives quality, effectiveness, efficiency and continuous improvement for P&O People Partnering and related processes. Embraces customer feedback to understand the customer journey with moments that matter and drives continuous improvement. Implement enhancements and modification as necessary to meet both the business and customer needs. Ensure compliance with local equity / Equal Employment Opportunity (EEO) regulations -First point of escalation for all leaders and managers on their day-to-day P&O topics, providing expert advice, guidance and support. Lead the delivery of in-country transformations, consult and negotiate with local works council / unions, provide advice and guidance for managers through the local process, oversee associate notice / handover meetings and overall restructuring lifecycle. Lead the execution of local implementation of large-scale organizational and day-to-day organizational structure changes, in line with country regulations / policies. Leads alignment and harmonization of local regulations with P&O Board; monitors compliance, risk management and review P&O controls (as part of the NFCM framework) working with People Partner team. Manage internal movement offers and mobility. Promotes the contribution of ideas and solutions to the P&O network (Country Business Partners, Global Business Partners and Country P&O Boards). Provide credible P&O People Partnering to people leaders, manager and associates offering advice and guidance on the moments that matter. Provides coaching and counselling to Country P&O Business Partners on local policies and processes. Seeks to establish strong relationships with cross-divisional P&O community members to understand needs and challenges and drive continuous improvement. Support and coach leaders, manager and associates on all P&O topics including promoting self-sufficiency in people processes. Support in country where there is no TAS presence. Key performance indicators: Demonstrate ability to leverage data and analytics for business insights to inform business decisions evidenced through positive client feedback. Demonstrate service delivery levels are within defined SLAs. Demonstrate simplification and optimization of local People Partner team processes (e. g. , time efficiencies, handoff reduction, quality improvement). Ensure compliance to global standards by meeting acceptable tolerances of risks / issues / audit findings. Lead and project manage the delivery of P&O initiatives against agreed timelines, scope and objectives (time, cost, quality). Monitor and ensure FTE cost control, operational costs, budgeting processes and SLAs are met and remain compliant. Minimum Requirements: Work Experience: Functional Breadth. Leading large and/or diverse multi-functional teams. Project Management. Operations Management and Execution. Representing the organization. Collaborating across boundaries. Skills: Business Acumen. Change Implementation. Coaching. Connecting The Dots. Data Analysis & Reporting. Empathy. Employee Lifecycle Management. Employee Relations & Engagement. Influencing. Matrix Collaboration. Operational Excellence. Performance Management. Project Management. Resilience. Stakeholder Management. Languages : English. Minimum Requirements: Experience: 7 to 12 years of work experience in a HR environment, preferably in the pharmaceutical industry. Experience supporting Sales and Marketing teams is a preference. MBA in HR or equivalent is a must (preferably full time) Strong stakeholder management, customer influence and influencing skills, capable to build relationships and work independently. Fluent in English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Remote / Bangalore, India | Contract/Internship + AI Engineering Intern Apply Overview As an AI Engineering Intern at EdVanD, you will collaborate with a cross-functional team to design, implement, and optimize AI-powered features for our educational platform. You will work on building secure and scalable APIs using Django or FastAPI, integrating LLMs via prompt engineering, and deploying AI services on AWS. This role is ideal for individuals passionate about AI, education, and product innovation. Responsibilities Build and maintain scalable RESTful APIs using Django or FastAPI Integrate and optimize large language models (LLMs) for various learning tasks Develop prompt engineering pipelines for AI content generation and personalization Deploy and manage AI services and APIs on AWS (Lambda, EC2, S3, etc.) Collaborate with frontend and product teams to deliver intelligent user experiences Write clean, modular, and well-documented code Participate in model evaluation, performance tracking, and continuous improvement Requirements Strong foundation in Python and backend development frameworks (Django/FastAPI preferred) Familiarity with prompt engineering and LLM-based API integration (OpenAI, Anthropic, etc.) Basic understanding of cloud platforms (AWS preferred) and deployment pipelines Experience working with REST APIs and JSON Excellent problem-solving and communication skills Passion for education and emerging AI technologies Benefits Hands-on experience with production-grade generative AI systems Mentorship from experienced engineers and AI practitioners Monthly stipend and potential for full-time conversion Access to premium learning resources and GPU credits Opportunity to build real-world solutions that impact K-12 education at scale