9090 Continuous Improvement Jobs - Page 38

Let s do this. Let s change the world. The Global HEOR Systematic Literature Review (SLR) Leader oversees the development and delivery of systematic literature review activities within Amgen s Global HEOR function. This operational and managerial role includes supervision of a team of Global HEOR SLR Analysts, ensuring high-quality, timely, and scientifically robust literature review outputs. The Global HEOR SLR Leader will align closely with Global HEOR TA Heads in support of global market access and value demonstration for Amgen s products across their lifecycle. Lead, mentor, and handle a team of Global HEOR SLR Analysts, fostering a high-performance culture. Oversee the design, execution, and quality control of systematic literature reviews across therapeutic areas. Supervise the development of research protocols, screening strategies, and data abstraction tools. Collaborate with HEOR TA Heads to align literature review outputs with HEOR strategy. Serve as the functional guide on literature review within HEOR. Ensure consistency with PRISMA, PICOS, and other industry standards for evidence synthesis. Support integration of SLRs into HTA submissions, global value dossiers, and peer-reviewed publications. Continuously improve workflows, tools, and methodologies to enhance review efficiency and quality. Contribute to hiring, training, and performance evaluations within the SLR team. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The HEOR Systematic Literature Review Leader we seek should possess these qualifications. Basic Qualifications & Experience: Doctorate degree in health economics, public health, Epidemiology, Pharmacy, life sciences or related field and 2 years of experience in systematic literature reviews and evidence synthesis in the pharmaceutical, biotech or consulting setting OR, Master s degree in Health Economics, Public Health, Epidemiology, Pharmacy, life sciences or related field and 8 to 10 years of experience in systematic literature reviews and evidence synthesis in the pharmaceutical, biotech or consulting setting OR, Bachelor s degree in Health Economics, Public Health, Epidemiology, Pharmacy, life sciences or related field and 10 to 14 years of experience in systematic literature reviews and evidence synthesis in the pharmaceutical, biotech or consulting setting OR, Diploma in Health Economics, Public Health, Epidemiology, Pharmacy, life sciences or related field and 14 to 18 years of experience in systematic literature reviews and evidence synthesis in the pharmaceutical, biotech or consulting setting 3+ years of experience in team management capacity. Skills & Competencies: Exceptional leadership, mentoring, and project management skills. Excellent English oral and written communication, with ability to tailor content to different key partners; past medical writing experience is a plus Advanced proficiency with systematic review tools and citation databases (e.g., PubMed, EMBASE). Skilled in Microsoft Office (Word, PowerPoint, Excel); experience with EndNote or other reference tools preferred. High attention to detail, quality assurance, and evidence integrity. Innovative use of artificial intelligence to boost efficiency Organizational Behaviors: Solution-oriented with a continuous improvement attitude. Strong interpersonal and customer engagement capabilities. Comfortable working in a distributed team across time zones and cultures. 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 Chromatography Data Systems (CDS) Product Team and will be responsible for driving Life Cycle Management of Empower, Chromeleon, Unicorn and other CDS applications, including GxP validation, testing, and compliance activities, remediation of software vulnerabilities, and managing backup and disaster recovery plans for CDS applications. You will work closely with Lab Scientists, Benchtop Technicians, Product owners, and Business analysts following SAFe Agile methodologies to drive Platform and Product Innovation beyond the KTLO activities to help accelerate Operational Business Goals and advance Amgen s mission of serving every patient every time Roles & Responsibilities: Oversee the software, hardware, and firmware development lifecycle for CDS application, ensuring standard methodologies in development, testing, and deployment across the Global Process Development Organization Work within the framework of SAFe product team, participating in requirements gathering, design discussions, development, implementation, testing, and software validation. Ensure the quality, reliability, and scalability of the CDS applications, following the standard methodologies of software engineering, testing, and documentation. Research and evaluate new technologies and frameworks that can enhance the capabilities and performance of the software solutions. Remain accountable for ensuring overall organizational compliance with quality and GxP in technology services Monitor emerging technologies and trends to find opportunities for platform growth and expansion Apply machine learning and Gen AI techniques to accelerate operational business process flows associated with CDS applications and leverage CDS data to generate insights and provide recommendations for process improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Doctorate degree OR Master s degree and 4 to 6 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Bachelor s degree and 6 to 8 years of Life Science / Biotechnology / Pharmacology / Information Systems experience OR Diploma and 10 to 12 years of Life Science / Biotechnology / Pharmacology / Information Systems experience Preferred Qualifications: Functional Skills: Must-Have Skills: Demonstrated experience of owning business applications in a Life Sciences, Pharmaceutical, Biotech company or equivalent industry or knowledge of the pharmaceutical industry GxP system qualification and validation processes for computer related systems Strong knowledge of COTS (Commercial-off-the-shelf) Validations on HPLCs, UPLCs, CEs, GCs, and other standalone systems Proven leadership skills with the ability to lead projects and work closely with a team of hard-working technology professionals Build a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements Solid skills in collaborating and communicating with multi-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. Experience with Advancing Capabilities and Delivering Innovative Technology Solutions in a Pharma/Biotech environment Degree in Computer Science, Information Systems, Engineering, or Life Sciences Good-to-Have Skills: At least 5 - 8 years of domain knowledge in health and/or life sciences combined with Information Technology Extensive experience in software development lifecycles Experience using and adoption of Scaled Agile Framework (SAFe) Understanding of ITIL processes and implementation Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products Soft Skills: Excellent leadership and team management skills. Strong transformation and change management experience. Ability to work effectively with global, virtual teams. Excellent analytical and troubleshooting skills. Ability to manage multiple priorities successfully. Strong presentation and public speaking skills. Strong verbal and written communication skills. High degree of initiative and self-motivation. 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 coach who facilitates team with Scrum events, processes, and supports teams in delivering value for Veeva Vault Team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, handling risks and dependencies, and driving relentless improvement. The Scrum master help 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 handle product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Capture the voice of the customer to define business processes and product needs Collaborate with business stakeholders, Architects and Engineering teams to prioritize release scopes and refine the Product backlog Lead and facilitate the 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 stakeholders 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 stakeholders 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 documentations 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. Develop a culture of collaboration, innovation, and continuous improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is with these qualifications. Basic Qualifications: Masters degree / Bachelors degree and 5 to 9 years in Software Development OR IT Development OR Related Field Preferred Qualifications: Must-Have Skills: 6-8 years of experience working in global pharmaceutical Industry Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager Vault etc. Good-to-Have Skills: Proficiency in automation tools and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodologies. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile etc.). Professional Certifications: SAFe for Teams (Must Have) Veeva Vault Platform Administrator (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 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.

We are seeking a Talent and Performance Platforms Manager to join our Talent Management and Technology team, focused on leading a team in driving global talent initiatives. This individual will play a pivotal role in the development, enhancement, and execution of our performance management process and Talent Marketplace strategy. In addition to managing a team, the Manager will directly contribute to key deliverables, collaborate with stakeholders across HR and business functions, and ensure operational excellence of talent management processes. Key Responsibilities Team Leadership & Development Lead, coach, and develop a team of Senior Associates on the Talent Management and Technology team Allocate work, ensure deliverables align with team priorities, and provide performance feedback. Foster a collaborative and results-driven team culture. System Enhancement & Optimization Partner with HR Technology teams to test, validate, and deploy platform enhancements in Workday and Eightfold. Ensure platform functionality aligns with business needs and user experience standards. Content Strategy & Training Review, refine, and oversee the creation of global training materials and process documentation. Ensure content quality, consistency, and accessibility across all mediums, including SharePoint and global language adaptations. Data Analytics & Reporting Provide strategic insights through data analysis and dashboards. Ensure the team delivers accurate and actionable data reports to the business, HR colleagues and leadership. Process Improvement Identify and implement process efficiencies across talent management workflows. Lead continuous improvement efforts. Communication & Change Management Draft high-level internal communications to support talent initiatives. Serve as a liaison with HR stakeholders

Let s do this. Let s change the world. An individual who thrives in ambiguity, capable of supporting strategic sourcing initiatives with speed and precision. You will support the identification, evaluation, and negotiation with suppliers to ensure the delivery of efficient and effective sourcing solutions that support our ambitious goals. Your responsibilities will include conducting in-depth market analysis, managing the sourcing process, provide guidance to junior staff members and engaging with suppliers and stakeholders to achieve optimal terms and performance. Roles & Responsibilities: Develop and execute global strategic sourcing initiatives to drive cost optimization, supplier performance, and risk management. Lead supplier evaluations, negotiations, and contract management to ensure best-in-class procurement practices. Analyze large datasets related to procurement, supplier performance, and market trends to identify cost-saving opportunities and operational efficiencies. Utilize data analytics tools to generate insights, create reports, and support strategic decision-making. Collaborate with senior leadership and cross-functional teams to align sourcing strategies with business objectives. Establish and manage key supplier relationships to enhance quality, innovation, and long-term value. Ensure compliance with procurement policies, risk mitigation strategies, and sustainability initiatives. Work effectively with internal stakeholders and suppliers, demonstrating strong communication and collaboration skills. Provide guidance to junior team members and contribute to a culture of continuous improvement. Functional Skills: Must-Have Skills: Proven Strategic Sourcing Experience Strong Supplier Negotiation skills Excellent analytical, problem solving and organizational skills Experience with Global Procurement e-Sourcing and CLM Tools (e.g., Workday Strategic Sourcing, Sirion Labs) Project Management Experience able to lead teams that cut across geographic and functional boundaries Good-to-Have Skills: Prior experience in managing teams Soft Skills: Strong verbal and written communication skills Ability to work effectively with global, virtual teams Ability to navigate ambiguity High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Influencing and Change Management skills Basic Qualifications: Bachelor s degree and 4-6 years of Sourcing, Management Consulting, or Project Management

We are seeking a highly skilled and experienced Test Automation Engineering Manager to lead our automation team. The ideal candidate will have expertise in data automation, especially with Databricks and AWS, and be skilled in search-related programs, Data catalog , and UI validation. you will play a pivotal role in shaping the quality and reliability of complex, search-driven applications that handle large-scale data ingestion and real-time querying. This is a highly hands-on leadership role , ideal for someone who enjoys diving deep into technical challenges while also mentoring and guiding QA strategies at scale. You will be responsible for defining and executing end-to-end test strategies from backend content crawling, document indexing, API interaction, to UI presentation and search experience . Youll work closely with cross-functional teams including backend engineers, frontend developers, data engineers, DevOps, and product owners , ensuring that all components of the system from data ingestion (via Java-based crawlers and S3 document pipelines) to frontend search display (built on React and GraphQL ) function seamlessly and perform reliably under real-world loads. In this role, you are expected to be a quality champion , not just ensuring functional correctness but also owning performance, usability, and scalability aspects of search testing. You ll be at the intersection of search technology , cloud platforms , and UI/UX , driving excellence through hands-on implementation and strategic leadership. Roles & Responsibilities: Hands-On Testing & Automation Design, implement, and maintain comprehensive test strategies across UI, backend, and data layers of search-driven platforms. Perform hands-on testing of React-based UIs integrated with GraphQL APIs, ensuring a seamless and accurate search experience for end-users. Develop and maintain automated test suites using tools like Cypress, Playwright, or Selenium, integrated into CI/CD pipelines. Create robust GraphQL API test scenarios to validate search results, metadata mapping, and performance under various data loads. Search Engine & Data Flow Testing Validate integration of custom search engines (e.g., GCP Search Engine) with frontend interfaces. Test and ensure end-to-end search result accuracy from Java-based web crawlers, S3 document ingestion, through to frontend UI. Verify the ingestion, parsing, indexing, and retrieval accuracy of documents stored in Amazon S3, including testing of content structure, metadata extraction, and search visibility. Collaborate with developers to test the effectiveness and coverage of Java crawlers, including content freshness, crawl depth, and data completeness. T echnical Leadership, Strategy & Team Collaboration Define and drive the overall QA and testing strategy for UI and search-related components with a focus on scalability, reliability, and performance. Contribute to system architecture and design discussions , bringing a strong quality and testability lens early into the development lifecycle. Lead test automation initiatives , introducing best practices and frameworks that align with modern DevOps and CI/CD environments. Mentor and guide QA engineers , fostering a collaborative, growth-oriented culture focused on continuous learning and technical excellence. Collaborate cross-functionally with product managers, developers, and DevOps to align quality efforts with business goals and release timelines. Conduct code reviews, test plan reviews, and pair-testing sessions to ensure team-level consistency and high-quality standards. Monitoring, Metrics & Continuous Improvement Define and track key quality metrics such as search accuracy, indexing delays, UI responsiveness, and test coverage. Drive continuous improvement initiatives in testing practices, tools, and frameworks. Participate in production validations, incident reviews, and apply learnings to build more resilient systems. Quality Monitoring & Continuous Improvement Define and track key quality metrics such as search accuracy, UI responsiveness, indexing delays, and automation coverage to ensure high product quality. Drive continuous improvement initiatives by identifying process gaps, enhancing test tools, and evolving testing strategies based on production feedback. Ensure robust release readiness by conducting risk assessments, regression testing, and cross-functional validation across the release cycle. Collaborate with DevOps to maintain reliable CI/CD pipelines that support automated testing, fast feedback, and post-release monitoring. Good-to-Have Skills: Familiarity with distributed systems, databases, and large-scale system architectures. Experienced with software engineering best-practices, including but not limited to version control (Git, Subversion, etc.), CI/CD (Jenkins, Maven etc.), automated unit testing, and Dev Ops knowledge of search-related programming and algorithms. Experience working with agile Testing methodologies such as Scaled Agile. Must-Have Skills: 10-14 years of QA experience with a strong focus on frontend, backend, and data-centric application testing. Hands-on experience with UI testing of modern frontend applications built in React.js. Strong knowledge of GraphQL APIs including schema validation, query testing, and performance benchmarking. Proven experience testing custom search engine implementations, preferably on Google Cloud Platform (GCP) or similar. Deep understanding of document ingestion pipelines and metadata validation using Amazon S3 or other object stores. Familiarity with Java-based web crawlers (e.g., Apache Nutch or in-house frameworks) testing content coverage, freshness, and crawl performance. Proficiency in test automation tools such as Cypress, Playwright, or Selenium including scripting and CI/CD integration. Experience with CI/CD tools like Jenkins, GitHub Actions, or GitLab CI for integrating test automation into release pipelines. Strong skills in debugging, log analysis, and issue triaging across distributed systems. Excellent communication skills with the ability to collaborate cross-functionally and lead QA efforts within agile teams. Education and Professional Certifications Bachelor s degree in computer science and engineering preferred, other Engineering field is considered; Master s degree and 6 + years experience Soft Skills: Excellent analytical and troubleshooting 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 EQUAL OPPORTUNITY STATEMENT .

Let s do this. Let s change the world. In this vital role you will develop an insight driven sensing capability with a focus on revolutionizing decision making. In this role you will lead the technical delivery for this capability as part of a team data engineers and software engineers. The team will rely on your leadership to own and refine the vision, feature prioritization, partner alignment, and experience leading solution delivery while building this ground-breaking new capability for Amgen. You will drive the software engineering side of the product release and will deliver for the outcomes. Lead delivery of overall product and product features from concept to end of life management of the product team comprising of technical engineers, product owners and data scientists to ensure that business, quality, and functional goals are met with each product release Drives excellence and quality for the respective product releases, collaborating with Partner teams. Impacts quality, efficiency and effectiveness of own team. Has substantial input into priorities. Incorporate and prioritize feature requests into product roadmap; Able to translate roadmap into execution Design and implement usability, quality, and delivery of a product or feature Plan releases and upgrades with no impacts to business Hands on expertise in driving quality and best in class Agile engineering practices Encourage and motivate the product team to deliver innovative and exciting solutions with an appropriate sense of urgency Handles progress of work and addresses production issues during sprints Communication with partners to make sure goals are clear and the vision is aligned with business objectives Direct management and staff development of team members Win What we expect of you As an Information Systems Senior Manager at Amgen, you will be responsible for managing and leading a team of IT professionals to deliver efficient and effective information systems solutions. You will collaborate with cross-functional key partners, supervise IT projects, ensure compliance with IT policies and standards, and drive continuous improvement in IT processes. Your strong leadership skills, technical expertise, and strategic mentality will enable you to effectively handle IT operations and contribute to the companys overall success. Basic Qualifications: 5+ years of managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources AND Doctorate degree and 2 years of Information Systems experience OR , Master s degree and 6 years of Information Systems experience OR , Bachelor s degree and 8 years of Information Systems experience OR , Associate s degree and 10 years of Information Systems experience Thorough understanding of modern web application development and delivery, Gen AI applications development, Data integration and enterprise data fabric concepts, methodologies, and technologies e.g. AWS technologies, Databricks Demonstrated experience in building strong teams with consistent practices. Demonstrated experience in navigating matrix organization and leading change. Prior experience writing business case documents and securing funding for product team delivery; Financial/Spend management for small to medium product teams is a plus. In-depth knowledge of Agile process and principles. Define success metrics for developer productivity metrics; on a monthly/quarterly basis analyze how the product team is performing against established KPI s. Functional Skills: Leadership: Influences through Collaboration : Builds direct and behind-the-scenes support for ideas by working collaboratively with others. Strategic Thinking : Anticipates downstream consequences and tailors influencing strategies to achieve positive outcomes. Transparent Decision-Making : Clearly articulates the rationale behind decisions and their potential implications, continuously reflecting on successes and failures to enhance performance and decision-making. Adaptive Leadership : Recognizes the need for change and actively participates in technical strategy planning. Preferred Qualifications: Strong influencing skills, influence stakeholders and be able to balance priorities. Prior experience in vendor management. Prior hands-on experience leading full stack development using infrastructure cloud services (AWS preferred) and cloud-native tools and design patterns (Containers, Serverless, Docker, etc.) Experience with developing solutions on AWS technologies such as S3, EMR, Spark, Athena, Redshift and others Familiarity with cloud security (AWS /Azure/ GCP) Conceptual understanding of DevOps tools (Ansible/ Chef / Puppet / Docker /Jenkins) Professional Certifications : Certified Scrum Master (CSM) or Professional Scrum Master (PSM) (preferred) AWS Certified Solutions Architect (preferred) Certified DevOps Engineer (preferred) Certified Agile Leader or similar (preferred) Soft Skills: Strong desire for continuous learning to pick new tools/technologies. High attention to detail is essential with critical thinking ability. Should be an active contributor on technological communities/forums Proactively engages with multi-functional teams to resolve issues and design solutions using critical thinking and analysis skills and best practices. Influences and energizes others toward the common vision and goal. Maintains excitement for a process and works towards new directions of meeting the goal even when odds and setbacks render one path impassable Established habit of proactive thinking and behavior and the desire and ability to self-start/learn and apply new technologies Excellent organizational and time-management skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to lead multiple priorities successfully. Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills.

The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry best practices for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Basic Qualifications and Experience: Total experience: 5-9 years At least 2-3 years in QC Bachelor s or Master s degree in Life Sciences or Pharmacy

Lets do this! Lets change the world! In this vital role you will report to the Executive Director, Talent Management and Development, and you will lead the Corporate Learning Programs team for Amgen. You are a learning and organizational professional, a team leader with a successful track record, familiar with effectively designing and delivering learning solutions, in partnership with vendors and leveraging new technologies for optimal impact. Corporate Learning Programs Lead the execution and evolution of Amgen s standard central learning program portfolio Be knowledgeable about and leverage the full range of programs, platforms, and performance support offerings the Corporate Learning Programs team offers in order to address learning concerns and improve individual and team performance When learning needs are identified, work with the client to curate a solution from existing resources or support development of new offerings by partnering with internal resources (e.g. Global Learning Solutions) or external partners (e.g. HF) Contribute to the evolution and continuous improvement of Amgen s L4G (Learning for Growth) globally Integrate learning with Amgen annual processes and leader effectiveness frameworks Ensure strong alignment across learning programs and annual talent & performance platforms to support execution of our priorities, effective talent management as well as development and growth of our staff globally Integrate and align with Amgen s leadership effectiveness frameworks and develop solutions to support individual leader effectiveness as well as the effectiveness of their teams Globalize and scale our Learning Programs practices: Promote the use of existing programs, platforms, and resources Partner with HR BPs and business clients to identify and onboard external consultants who can deliver solutions aligned with best practices and Talent priorities. For business-essential opportunities, work with the HR Business Partners to design and evolve our central programs Consistently communicate, within our tiered service delivery model, to ensure effective connection between client needs and our programs Talent Management & HR Technology Team Member Evaluate the effectiveness and impact of Corporate Learning Programs and Team & Leader Effectiveness frameworks Contribute to analysis aimed at ensuring our team is addressing the most important business needs and finding opportunities to build scalable solutions Communicate to Team, Talent, HR, and cross-functional Learning & Performance stakeholders to ensure best practices are identified and shared Qualifications & Experience :- Masters degree & 4 years of Human Resources and/or Learning & Performance experience Or Bachelors degree & 6 years of Human Resources and/or Learning & Performance experience Experience working in a Center of Excellence (i.e., Talent Management, Organizational Development, Learning & Development) Experience in performance consulting and needs analysis Knowledge of organizational behavior, group dynamics, strategic planning, change management, and organization design Able to translate theory into business terms and concepts into concrete, achievable actions Collaborative work style with ability to solicit input, influence without authority, and support decision making Self-directed and willing to take informed risks Experience using change management methodologies/models to implement organization change initiatives Interpersonal skills and experience working with leaders, identifying needs, developing action plans, identifying deliverables, and presenting results/recommendations Project planning and management skills, plus ability to manage multiple workstreams simultaneously Knowledge of adult learning methodologies, instructional design, and curriculum development Experience using ADDIES, Agile, or other design and development methodologies in the creation of learning solutions Knowledge of integrated talent systems/platforms .

The Sr Associate Supplier Quality position is responsible for the Quality and Compliance Oversight of Raw material suppliers. This position is responsible for being an integral quality member of the Amgen multi-functional raw materials suppliers team that includes but is not limited to business operations, analytical science, process development, and supply chain. Role Description Working independently, the individual will be responsible for, but not limited to the following: Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations Collaborate with raw material suppliers to ensure alignment to quality agreements, identifying performance improvement opportunities Understand and incorporate risk management strategy into the overall raw material lifecycle Provide support to the supplier periodic monitoring oversight activities Support in tactical activities related to internal/external audits and inspections Perform routine quality assessments and provide approval of changes to raw material inspection profiles Take part in operational improvement initiatives, programs, and projects Develop solutions that are thorough, practical, and consistent with functional objectives Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships Work under minimal supervision in line with Amgen Values and Leadership Attributes What we expect of you Education and Experiences: We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications: Bachelor s degree in science or engineering and 2+ years of professional experience in related fields Understanding of GMP/GDP requirements Familiarity with raw material compendial testing Experience overseeing quality of suppliers or external parties Deep technical writing skills Preferred Qualifications Strong continuous improvement approach and lean practices experience Understanding of end-to-end supply chain business processes Experience in project management across multiple departments and geographies Quick process understanding, insight and visualizing Strong analytical and problem-solving skills Independent self-starter, able to work autonomously, under pressure and in teams GMP/GDP knowledge and understanding of pharmaceutical regulations Energetic, detail oriented, highly motivated with a can do outlook Change management skills Ability to communicate across all levels of the organization Effective written and verbal communication skills Experience with Microsoft Office Tools including Excel, Word, and PowerPoint Ability to multi-task and prioritize 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 Lead and handle product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Capture the voice of the customer to define business processes and product needs Collaborate with business collaborators, Architects and Engineering teams to prioritize release scopes and refine the Product backlog Lead and facilitate the 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 documentations 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. Develop a culture of collaboration, innovation, and continuous improvement Basic Qualifications and Experience: Masters degree / Bachelors degree and 5 to 9 years Functional Skills: Must-Have Skills: 6-8 years of experience working in global pharmaceutical Industry Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Good communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager Vault etc. Good-to-Have Skills: Proficiency in automation tools and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodologies. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile etc.). Professional Certifications: SAFe for Teams (Must-Have) Veeva Vault Platform Administrator (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. 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.

This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role maximises scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements scientific software platforms for different Research imaging techniques such as Digital Pathology, High Content Screening (HCS), cell imaging, cryo-EM, etc. You will implement and manage imaging capabilities across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and landmarks Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. 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 1 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Bachelor s degree with 3 - 5years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma with 7 - 9 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/ Bioinformatics or related field Functional Skills: Must-Have Skills: 3+ years of experience in designing and supporting Research imaging platforms. Demonstrated 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 Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience with Proscia Concentriq, Deciphex Patholytix, HALO, Visiopharm, Revvity Signals Image Artist, Imaris, PSILO or similar imaging platforms Preferred Qualifications: Experience with Agile software development methodologies (Scrum) Experience performing or enabling image analysis from microscopes Ability to communicate technical or complex subject matters in business terms Knowledge of business analysis standard processes, DevOps, Continuous Integration, and Continuous Delivery methodology Experience with cloud (e.g. AWS) and on-premise infrastructure Experience designing and supporting scientific software platforms in biopharma Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision 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 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.

In this vital role you will coach who facilitates team with Scrum events, processes, and supports teams in delivering value for Veeva Vault Team. The role involves facilitating communication and collaboration among teams, ensuring alignment with the program vision, handling risks and dependencies, and driving relentless improvement. The Scrum master help 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 handle product delivery using agile frameworks and techniques. Align with Agile values such as prioritizing individuals and interactions over processes and tools for Veeva Vault systems Team. Capture the voice of the customer to define business processes and product needs Collaborate with business partners, Architects and Engineering teams to prioritize release scopes and refine the Product backlog Lead and facilitate the 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 partners 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 partners 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 documentations 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. Develop a culture of collaboration, innovation, and continuous improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelor s degree and 3 to 5 years of Computer Science, IT or related field experience OR Diploma and 7 to 9 years of Computer Science, IT or related field experience Functional Skills: Must-Have Skills: 6-8 years of experience working in global pharmaceutical Industry Solid understanding of GxP regulations, specifically 21 CFR Part 11. Expertise in defining and implementing validation strategies aligned with regulatory requirements. Experience in creating and driving validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)). Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity. Familiarity with GxP Validation management tools such as ALM, Veeva Validation Manager Vault etc. Preferred Qualifications: Proficiency in automation tools and validation software. Experience of DevOps, Continuous Integration and Continuous Delivery methodologies. Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies (Scrum Agile etc.). Professional Certifications: SAFe for Teams (preferred) Veeva Vault Platform Administrator (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. 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 conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns 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. Ensures quality of complaint records Applies analytical abilities to evaluate complex situations using multiple sources of information Execution of regulatory and SOP requirements Anticipates and prevents potential issues with regulators Provides guidance and technical advice Evaluates subject matter expert assessments Raises potential Quality issues to Management 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 Specialist Quality Complaints experience OR , Bachelor s degree and 6 to 8 years of Specialist Quality Complaints experience OR , Diploma and 10 to 12 years of Specialist Quality Complaints experience Preferred Qualifications: Quality and manufacturing experience in biotech or pharmaceutical industry Ability to oversee multiple projects simultaneously Ability to successfully handle workload to timelines Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time, and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) 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 responsible for developing and maintaining the overall IT architecture of the organization. This role involves defining the architecture vision, creating roadmaps, and ensuring that IT strategies align with business goals in the Hire to Retire capability and more specifically to Workday HCM and Talent Performance. You will be working closely with partners to understand requirements, develop architectural blueprints, and ensure that solutions are scalable, secure, and aligned with enterprise standards. Architects will be involved in defining the enterprise architecture strategy, guiding technology decisions, and ensuring that all IT projects adhere to established architectural principles. Roles & Responsibilities: Develop and maintain the enterprise architecture vision and strategy, ensuring alignment with business objectives for Workday and Eightfold platforms. Create and maintain architectural roadmaps that guide the evolution of IT systems and capabilities for Workday and Eightfold platforms. Establish and enforce architectural standards, policies, and governance frameworks Evaluate emerging technologies and assess their potential impact on the architecture Identify and mitigate architectural risks, ensuring that IT systems are scalable, secure, and resilient Maintain comprehensive documentation of the architecture, including principles, standards, 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 Evaluate and recommend technologies and tools that best fit the solution requirements for Human Capital Management processes Design systems that can scale to meet growing business needs and performance demands Develop and maintain logical, physical, and conceptual data models to support business needs Design and manage metadata structures to enhance information retrieval and usability 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 Computer Science, IT or related field experience OR Bachelor s degree and 6 to 8 years of Computer Science, IT or related field experience OR Diploma and 10 to 12 years of Computer Science, IT or related field experience Preferred Qualifications: Must-Have Skills: Strong architectural design and modeling skills. Experience directing solution design, business processes redesign and aligning business requirements to technical solutions in a regulated environment. Experience configuring Workday Recruiting and Talent Management business processes (Job Application, Offer, Employment Agreement, Performance, Goals, Career, Talent Review, Skills, etc.). Experience with Workday Report development including creation of complex calc fields. Functional knowledge that works in conjunction with Workday Recruiting and Performance, including HCM, Compensation, Integrations, etc. [Business Architect] Business Strategy: Alignment of IT capabilities with business strategy. Business Process Reengineering: Ability to identify and improve inefficiencies in business processes. Non-Functional Requirements: Consideration of factors like performance, scalability, security, and reliability in system design. Organizational Change Management: Experience in leading organizational change initiatives driven by business transformation. Partner Engagement: Effective communication and collaboration with business partners at all levels. Security: Understanding of API security best practices and standards. 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 Professional Certifications: Workday HCM, T&A, Recruiting, Integrations (preferred) Soft Skills: Excellent critical-thinking and problem-solving skills Strong 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.

Let s do this. Let s change the world. In this vital role you will contribute to Amgen s pipeline of new molecules and commercial products, that are treating serious illnesses and transforming lives. The Specialist CMC Statistician will be a member of our Global CMC Statistics (GCS) team. The mission of the team is to design, develop, and promote best practices, processes and tools across Operations that drive consistency and improve compliance. As part of the GCS team, the Specialist CMC Statistician will work with members of the team to implement statistical tools and techniques to support product manufacturing and testing throughout the product life cycle. The statistician will provide support to clinical and commercial manufacturing sites in the network. This involves statistical support for analyzing Operations generated data including monitoring programs, analytical methods, investigations, and other ad-hoc analyses as required. The Specialist CMC statistician will also support development of delivery devices and systems, and provide statistical analysis, study designs, acceptance sampling plans and acceptance criteria for the development, qualification, and transfer of physical test methods. They will also establish appropriate study designs and carry out evaluation of acceptance criteria for Design Verification testing ensuring that the overall program is aligned with Amgen and Regulatory/ISO requirements. Finally, the candidate will contribute to continuous improvement efforts across Amgen s networks, leading to harmonization, efficiency gains and scientific innovation and, administration of statistical training for Amgen s engineers and scientists. Primary Responsibilities for the Specialist CMC Statistician include: Provides continuous statistical support to a site or functional group by collaborating with technical associates to develop an experimental study, perform statistical analysis, and document results in a technical report that aligns with Amgen s document control system and has statistical integrity. Provides written responses to clarify and/or explain a statistical approach and performs additional analysis to support regulatory submissions and response to questions, as required. Participates in the development, implementation and maintenance of statistical tools used to support product life cycle activities assisting with drafting/updating white papers, writing standardized R and SAS code, outlining report templates, and aligning GCS duties in relevant SOPs. Participates in improvement efforts to promote statistical techniques used in biologics and monoclonal antibodies processes; and mentors and guides statistical techniques and software tools to technical associates. Stays up to date on biotechnology industry trends, best practices, guidance documents and participates in external conferences, as appropriate What we expect of you We are all different, yet we all use our unique contributions to serve patients. The highly motivated professional we seek is a collaborate partner with these qualifications. Basic Qualifications: Doctorate degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics or Master s degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 3 years of experience or Bachelors degree in Applied Statistics, Industrial Statistics or Non-clinical Biostatistics and 5 years of experience or Associates degree and 10 years of experience Preferred Qualifications: Advanced degree in Applied or Industrial Statistics with 3 years experience applying statistical methodologies to support Biopharma manufacturing and control Proficient in statistical tools and techniques commonly used in biopharma manufacturing and testing operations, such as Design of Experiments, Statistical Process Control, Process Capability Analysis, Measurement System Analysis, Acceptance Sampling Plans, Non-linear and Linear Regression, Significance Tests, and Simulation. Proficient in SAS and/or R programming (data manipulation techniques, macro, statistical and graphical PROCS, and ODS) and JMP statistical software Excellent interpersonal, oral and written communication 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.

Let s do this. Let s change the world. In this vital role you will responsible for developing and maintaining the overall IT architecture of the organization. In this role you will be responsible for designing and implementing information system architectures to support business needs. You will analyze requirements, develop architectural designs, evaluate technology solutions, and ensure alignment with industry best practices and standards. You will be working closely with collaborators to understand requirements, develop architectural blueprints, and ensure that solutions are scalable, secure, and aligned with enterprise standards. Architects will be involved in defining the enterprise architecture strategy, guiding technology decisions, and ensuring that all IT projects adhere to established architectural principles. Roles & Responsibilities: Develop and maintain the enterprise architecture vision and strategy, ensuring alignment with business objectives for Corporate Functions data architecture. Collaborating closely with business clients and key collaborators to align solutions with strategic objectives. Create and maintain architectural roadmaps that guide the evolution of IT systems and capabilities for Corporate Functions data architecture Establish and enforce architectural standards, policies, and governance frameworks Evaluate emerging technologies and assess their potential impact on the solution architecture Identify and mitigate architectural risks, ensuring that IT systems are scalable, secure, and resilient Maintain comprehensive documentation of the architecture, including principles, standards, 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 Ensure seamless integration between systems and platforms, both within the organization and with external partners Design systems that can scale to meet growing business needs and performance demands Deliver high-quality Salesforce solutions using LWC, Apex, Flows and other Salesforce technologies. Ensure alignment to established standard methodologies and definitions of done, maintaining high-quality standards in work Create architectural design and data model as per business requirements and Salesforce standard methodologies Proactively identify technical debt and collaborate with the Principal Architect and Product Owner to prioritize and address it effectively Negotiate solutions to complex problems with both the product teams and third-party service providers Build relationships and work with product teams; contribute to broader goals and growth beyond the scope of a single or your current project What we expect of you We are all different, yet we all use our unique contributions to serve patients. Doctorate degree / Masters degree / Bachelors degree and 8 to 13 years of Computer Science, IT or related field experience Preferred Qualifications: Strong architectural design and modeling skills Proficiency in Salesforce Health Cloud / Service Cloud implementation for a Call Center Solid hands-on experience of implementing Salesforce Configurations, Apex, LWC and integrations Solid understanding of declarative tools like Flows and Process Builder Proficiency in using Salesforce tools such as Data Loader, Salesforce Inspector to query, manipulate and export data Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Ability to train and guide junior developers in standard methodologies Familiarity with Agile practices such as User Story Creation and, sprint planning Experience creating proofs of concept (PoCs) to validate new ideas or backlog items. Professional Certifications: Salesforce Admin Salesforce Advanced Administrator Salesforce Platform Developer 1 (Mandatory) Salesforce Platform Developer 2 Platform Builder Salesforce Application Architect Salesforce Health Cloud Accredited Professional (Preferred) Soft Skills: 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.

Let s do this. Let s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelor s degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance. 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, a Scrum Master drives Agile execution and continuous improvement within Scaled Agile ( SAFe ) environments. The Scrum Master will serve as a servant leader, facilitating Agile ceremonies, coaching teams, and enabling Agile Release Trains (ARTs) to deliver high-value solutions efficiently. The ideal candidate will have extensive experience in SAFe , Agile coaching, cross-team collaboration, and enterprise Agile transformation, ensuring alignment between teams, business objectives , and Lean-Agile principles. Act as a Scrum Master within a Scaled Agile ( SAFe ) environment, facilitating Agile ceremonies such as PI Planning, Scrum of Scrums, Sprint Planning, Daily Stand-ups, Sprint Reviews, and Inspect & Adapt sessions. Guide and support Agile teams, Product Owners, and collaborators, fostering self-organization, cross-team collaboration, and high-performance delivery. Coach Agile Release Train (ART) teams on SAFe standard methodologies, Lean-Agile principles, and Agile mentality adoption. Facilitate Program Increment (PI) Planning and ART synchronization, ensuring clear dependencies, objectives , and risk mitigation strategies. Remove organizational and technical impediments, enabling teams to deliver value faster and with higher quality. Promote continuous improvement and relentless execution, guiding teams in identifying and implementing retrospective action items. Assist Product Owners and Business Owners in effective backlog management, prioritization, and value-driven decision-making. Champion an environment of clarity, psychological safety, and accountability, enabling trust and continuous learning. Drive SAFe Lean Portfolio Management practices, ensuring alignment between critical initiatives and Agile execution. Enable Agile metrics tracking and reporting, demonstrating KPIs such as Velocity, Flow Efficiency, Lead Time, and Predictability to measure team progress. Collaborate with Release Train Engineers (RTEs), Solution Architects, and DevOps teams to optimize delivery pipelines and Agile execution. Promote DevOps and CI/CD adoption, fostering a culture of Lean-Agile technical excellence and innovation. Stay updated with SAFe and Agile industry trends, continuously improving Agile methodologies, frameworks, and tools. Play key role in building and leading a team of Scrum Masters What we expect of you Any Degree 8-13 years of experience in relevant field Basic Qualifications: SAFe Certified Scrum Master (SSM), SAFe Advanced Scrum Master (SASM), or SAFe Release Train Engineer (RTE) certification. Hands-on experience with Agile Portfolio Management and Agile Governance. Experience as a Scrum Master in Agile and SAFe environments. Deep understanding of SAFe principles, Agile Release Trains (ARTs), Lean-Agile frameworks, and Agile coaching. Hands-on experience with SAFe Agile ceremonies, PI Planning, Scrum of Scrums, Inspect & Adapt, and Iteration execution. Strong knowledge of Agile methodologies (Scrum, Kanban, XP, SAFe ) and enterprise Agile transformations. Proficiency in Agile project management tools (JIRA, Rally, Azure DevOps, Confluence, Miro). Experience with Lean Portfolio Management (LPM), Lean-Agile metrics, and flow-based work management. Ability to coach, mentor, and empower Agile teams, fostering collaboration, servant leadership, and dedication. Strong communication and collaborator management skills, ensuring alignment across business and technical teams. Understanding of DevOps, CI/CD, Test Automation, and Agile Quality Assurance. Proven ability to resolve conflicts, remove blockers, and optimize team performance. Preferred Qualifications: Domain experience with Biotech/Pharma industry is a plus Additional certifications in Certified Scrum Master (CSM), Professional Scrum Master (PSM), or SAFe Agilist (SA). Experience in leading SAFe implementations, Agile transformations, and enterprise Agile coaching. Knowledge of Value Stream Mapping, Lean Thinking, and OKR-based goal setting. Soft Skills: Excellent analytical and fixing 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. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills.

Let s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved techniques and procedures. In this position you will monitor activities through internal review and risk assessments of GxP systems per Amgen s policies and procedures. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. As Senior Manager Quality Assurance in the IT Quality organization, you re in a leadership position with responsibilities to supervise and mentor staff. Each staff member will participate/support different phases of the Information Systems Lifecycle. As a leader you will focus your efforts on the following workflows in a GxP environment: Focus Areas Computer System Validation (CSV) with a strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Strong understanding of periodic reviews and audit trail assessments for computer system validations, ensuring compliance, system integrity, and risk identification. Manages supplier relationships for software applications, including vendor selection and qualification, contract management, and ensuring timely and quality software delivery. Oversees the Quality Management System (QMS) for computerized systems, ensuring compliance, documentation, and continuous process improvement. Responsibilities Strong project management skills with experience supervising quality professionals working with cross functional and global stakeholders across multiple time zones. Develop, Mentor, and oversee staff and day-to-day GxP activities. Assess and guide the team in performing Periodic Review of Systems and Audit Trail Reviews. Manage change controls, validation and review and approval of validation deliverables per procedure (e.g. Validation Plan, Test Strategy, Validation Summary Report, etc.). Supplier Management activities for Computerized Systems and other validation disciplines/processes (e.g. Equipment, Analytical, etc.) Support, review and approval of failure investigations & CAPA as a Quality Contact pertaining to Computer Systems. Business Owner activities for systems owned by Quality Assurance (e.g. SAP QM, Veeva, Kneat). Participation and support of regulatory inspections as needed. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems. The following are some examples of tasks for the position Strong understanding of Risks Assessment and how to apply risk-based decision making to all processes related to IT systems. Determine and establish requirements for system/equipment or processes. Act as a reviewer and approver for SOPs, validation deliverables and /or QMS related records (Deviation/CAPA). Review and Approve System Life Cycle Documents (i.e. Validation deliverables). Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. Leverages qualitative insights and quantitative research, analyzes trending data, and utilizes forecasting models and advanced analytical tools to drive continuous improvement in IT quality and performance. Anticipates and prevents potential problems. Independently develop solutions that are thorough, practical and consistent with functional objectives. Provides management review updates on quality metrics, analyzing data and recommending improvements to enhance quality standards. Bring topics and critical decisions to management s attention and initiate and enforce necessary improvements and corrections to established systems and processes compliance. Basic Qualification Master s degree with a minimum of 10 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration) OR Bachelor s degree with a minimum of 14 years experience in Software and Systems Quality assurance (Experience of minimum 5 years in leading teams in this area of expertise and foster an environment of strong collaboration). Strong understanding and ability to apply GxP requirements in Information systems. Possesses a strong understanding of industry standards and business principles. Contributes to work group/team by ensuring quality of tasks/ services provided by self and others. Candidate may need to work hours outside the standard workday or work in different time zones to support business needs. Preferred skills Demonstrated experience (3-5 years) training others in activities outline above. Establish/Improve and actively participate in training curriculum and delivery of this material. 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.

Let s do this. Let s change the world. In this vital role you will be 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 direct the Agile Platform Technical team, consisting of software engineers, solution architects, system configurators, etc. to build shared platform components and their lifecycle management. 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 cross-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 pivotal initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Manage and be responsible for the identified Agile Product Team Be responsible for orchestrating product governance via PI planning, aligned to short- and long-term business and technology strategy needs Drive the implementation of a robust DevOps pipeline for the product using Amgen s CI/CD frameworks and tools Drive a Product First attitude among the team and peers with a goal towards global expansion of the product s capabilities Drive an attitude of excellence in running robust, reliable, and secure software products following Amgen s software development, operating procedures, and organizational change requirements Unblock and drive engagement to improve results delivery for the team and the organization 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. Improve activities being measured by crafting, monitoring, and optimizing relevant feedback loops through test & learn activities Facilitate standard methodology sharing, ensuring ongoing alignment with the Technology & Digital strategy Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy Establish Product/Platform Efficiency through coordinated impact assessment of Veeva changes and being accountable for deployment and adoption of platform features What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 2 years of Business, Engineering, IT or related field experience OR Master s degree and 8 to 10 years of Business, Engineering, IT or related field experience OR Bachelor s degree and 10 to 14 years of Business, Engineering, IT or related field experience OR Diploma and 14 to 18 years of Engineering, IT or related field experience Preferred Qualifications: Functional Skills: Must-Have Skills: Good knowledge of different Pharma business processes and Global regulations. Significant technical experience developing & architecting technology solutions, managing complex IS programs/projects, and driving multi-functional technology introduction and innovation in the life sciences industry 8 to 10 years of experience as a technical platform or technical product manager for Veeva Platforms and/or Products Good Experience with GxP Validation processes Experienced in managing a large team of 15+ members Experience with system integration and IT infrastructure Have strong eye for business. Can demonstrate a deep understanding of pharma industry regulations, therapy, and product Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent. Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc. Good-to-Have Skills: Experience as a technical platform or a product manager Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle of GxP Systems. 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 Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): Veeva Vault Platform Administrator (mandatory) Scaled Agile Framework (SAFe) for Teams (mandatory) Scaled Agile Framework (SAFe) - DevOps Practitioner (preferred) ITIL (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. 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. Equal opportunity statement 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 Senior Manager - Technology, will lead and coordinate cross-functional technology teams with a focus on Omics and Multi-Omics product development to enable target and biomarker discovery. This role combines strategic leadership, product ownership, and operational oversight, with a strong emphasis on global collaboration. This hands-on leader is primarily responsible for maximizing the value delivered by the team by ensuring that the team backlog is aligned with end-user and stakeholders needs across R&D. This role involves close collaboration with Architecture and Engineering leads supporting product teams along with scientific community representative stakeholders across R&D to define and prioritize features and provide a roadmap for feature development. The ideal candidate has strong experience in product management, specifically related to products that deliver Omics data technologies that enable scientists to perform high throughput analytics to elucidate disease biology, mechanism of action and pathway analysis. The role requires exceptional communication skills, and a deep understanding of Agile methodologies. Roles & Responsibilities: Manage and mentor junior technology staff across product teams, fostering a culture of innovation, accountability, continuous improvement and a sense of belonging. Collaborate and align with global product owners to ensure product teams are committed and focused on delivering on SAFe PI objectives for the business Define and communicate the product feature vision, including both technical / architectural features and enablement, and end-user features, ensuring alignment with business objectives across multiple solution stakeholder groups Create, prioritize, and maintain the feature backlog, ensuring that it reflects the needs of the business and stakeholders Collaborate with stakeholders to gather and document product requirements, user stories, and acceptance criteria Work closely with the business teams, Scrum Master and development team to plan and execute sprints, ensuring that the highest priority features are delivered Identify opportunities to improve the product / platform / system and development process, and make data-driven decisions to enhance the product / platform Oversee the day-to-day management of technology platforms, ensuring that they meet performance, security, and availability requirements Manage relationships with product / platform /system vendors, ensuring that service levels are met and that the organization derives the best value from its investments Ensure that platforms comply with security standards, regulatory requirements, and organizational policies Oversee the management and operation of specific IT systems, ensuring that they meet performance, security, and availability requirements Manage product team Architects, Analysts and Validation Engineers and provide role-based standards and career mentorship for these roles Assure that the team is successfully creating robust written materials, including product documentation, product backlog and user stories, and creating other need artifacts to assure efficient and effective coordination across time zones. Analyze product performance data, customer behavior, and market trends to inform product decisions Create and maintain reports and dashboards that provide insights into product performance, user engagement, and other key metrics Conduct market research and competitive analysis to identify opportunities and inform product strategy Analyze customer feedback and support data to identify pain points and opportunities for product improvement What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications and Experience: Doctorate degree / Masters degree / Bachelors degree and 12 to 17 years of experience in Life Sciences, Computer Science, IT, Computational Biology/Bioinformatics or related field. Must-Have Skills: Strong knowledge of Agile methodologies (SAFe) and product management principles, and backlog and feature management tools including Jira and Confluence Strong knowledge of IT service management (ITSM) principles and methodologies Extensive experience in leading teams, mentoring junior professionals, and cultivating the next generation of talent Strong communication and organizational abilities with a proven capacity to manage multiple priorities effectively. Proven record of implementing technology solutions in a large organization Good-to-Have Skills: Good Knowledge of the Global Pharmaceutical Industry Understanding of GxP process Strong solution design and problem-solving skills Strong understanding of technology, function, or platform Experience in developing differentiated and deliverable solutions Ability to analyze client requirements and translate them into solutions Working late hours Professional Certifications: Experience with current cloud technologies (AWS, Azure etc.), use of AI and large language models (LLMs), programming languages (Python, R) Experience working in biopharma R&D with emphasis on implementing research technologies Knowledge of GxP system validation processes Soft Skills: Excellent analytical and troubleshooting skills Highest degree of initiative and self-motivation Strong verbal and written communication skills, including presentation of varied audiences through complex technical/business topics Confidence in leading teams through prioritization and sequencing discussions, including managing stakeholder expectations Ability to work effectively with global, virtual teams, leveraging tools and artifacts available to assure clear and efficient collaboration across time zones Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong problem solving, analytical skills Ability to learn quickly and retain and synthesize complex information from diverse sources 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

The Global Submission and Information Management (GSIM) team brings strategic technical expertise to drive operational excellence, innovation, and technical compliance for Amgens global regulatory submission and information management. Ensures smooth, compliant data flows among functional areas, external partners, and regulatory authorities while designing and implementing process improvements, digital technologies, data standards, and organizational change management to achieve business results. The Senior Manager of Regulatory Data Management will help shape and implement the system based framework for regulatory data management at Amgen. The role involves leading the Data Management team in AIN, engaging with GSIM leadership and cross-functional partners who use the company Regulatory Information Management system. This role is pivotal in building and leading an impactful team from the ground up, ensuring the delivery of key operational metrics and maintaining compliance. Build and lead an impactful team, focused on delivering global regulatory data management services within the regulatory information management system. Develop a collaborative and inclusive team culture that promotes innovation and continuous improvement. Ensure the team meets key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency. Drive continuous improvement initiatives to enhance service delivery and operational processes. Minimize potential errors by establishing policies & processes for data usage. Supervise the provision of high-quality data processing, system utilisation and data management services to global clients. Develop and implement comprehensive training programs to ensure team members are skilled and knowledgeable in regulatory data management practices. Stay abreast of regulatory developments and ensure the team is follows all relevant regulations and standards. What we expect of you Basic Qualifications: Doctorate degree and 2 years of regulatory systems experience OR Master s degree and 8 to 10 years of regulatory systems experience OR Bachelor s degree and 10 to 14 years of regulatory systems experience OR Diploma and 14 to 18 years of regulatory systems experience OR Advanced knowledge of Veeva Vault RIM Proven leadership in regulatory data management Hands-on ability to work on data-centric processes and systems. Strong Knowledge of handling structured and unstructured data Demonstrated excellence in change management and key customer engagement. Preferred Qualifications: Experience with delivering compliance assurance within a large company Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry. 5 years of proven experience in regulatory operations, submission management. Excellent understanding of Regulatory Affairs business complexity and process interdependencies Experience with regulatory data in Regulatory Affairs, Research, Development, Quality Management, or related area. Demonstrated experience in building and leading successful teams. Sharp learning agility and analytical thinking Proven and advanced interaction with global key customers 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 Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation. Evaluates and ensures triaged product complaint records align with applicable procedures Evaluates and owns complaint records with basic investigations Ensures quality of complaint records Completes assigned assessments per applicable procedures Applies analytical skills to evaluate sophisticated situations using multiple sources of information Implements the complaint process per SOP requirements Owns or manages 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: Master s degree and 1 to 3 years of Quality experience OR Bachelor s degree and 3 to 5 years of Quality experience OR Diploma and 7 to 9 years of Quality experience Preferred Qualifications: Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry Bachelor s Degree in a Science Field Ability to successfully manage workload to timelines Familiarity with basic project management tools Ability to operate in a matrixed or team environment with site, functional, and senior management leadership Experience in driving decision making by using the 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 position after taking feedback from multiple sources Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results 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.

The Senior Associate, External Workforce is responsible for managing Amgen s External Workforce Program in partnership with Master Service Providers (MSPs), ensuring adherence to internal policies and local labor and tax regulations. The role includes supporting the Vendor Management System (VMS) and driving initiatives to improve workforce operations and compliance. This individual will act as a key liaison between internal stakeholders and external partners, supporting global projects that enhance workforce engagement and program effectiveness. Key Responsibilities Include: Serve as a compliance gatekeeper for the External Workforce Policy. Oversee day-to-day MSP operations aligned with contract SLAs and KPIs. Partner with business units to understand temporary workforce needs and drive continuous improvement. Manage external worker visa processes (U.S. only). Coordinate onboarding and offboarding to ensure policy and legal compliance. Maintain accurate records of external workers using VMS (e.g., Fieldglass) or HCM systems (e.g., Workday). Support procurement and HR teams with vendor contracts, extensions, and invoicing. Act as a liaison between Amgen teams and workforce vendors. Monitor tenure, budget utilization, and worker classification compliance. Assist with audits, risk assessments, and compliance checks. Resolve time tracking, billing, and onboarding issues efficiently. Contribute to continuous improvement of the external workforce program. Workforce Coordination: Collaborate with managers to identify staffing needs and source appropriate talent. Support recruitment and onboarding to align workers with project goals. Maintain a central database of external workforce members. Contract Management: Assist in negotiating and drafting compliant contracts for external workers. Ensure timely and accurate payment aligned with contract terms. Compliance & Documentation: Enforce compliance with company policies and labor regulations. Maintain records related to contracts, timesheets, and performance. Performance Monitoring: Conduct regular check-ins to assess performance and address concerns. Manage issues professionally and ensure alignment with company standards. Vendor Relationship Management: Maintain strong relationships with staffing agencies and vendors. Monitor performance and renegotiate terms as needed. Reporting & Analytics: Generate reports on workforce usage, costs, and productivity. Analyze trends and recommend optimizations. Training & Development: Coordinate training to ensure external workers meet organizational expectations. Win What we expect from you: Bachelor s degree in Human Resources, Business Administration, or related field (preferred). 2-4 years experience in HR, procurement, or contingent workforce management. Familiarity with VMS (Fieldglass) and HCM systems (Workday). Proficiency in Microsoft Office, especially Excel and Outlook. Strong organizational, communication, and multitasking skills. Ability to collaborate across cross-functional and global teams. High attention to detail with a focus on compliance and process improvement. Knowledge of labor regulations and contingent labor best practices is a plus. Experience in a matrixed or multinational organization is advantageous. Thrive What you can expect from us: At Amgen, while we focus on improving the lives of patients, we re equally committed to supporting the growth and well-being of our team. You can expect a competitive salary, a comprehensive Total Rewards plan including health and welfare benefits for you and eligible dependents financial savings programs, career development opportunities, and initiatives that support work-life balance. .