Information Security GxP Manager

At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let s do this. Let s change the world. In this vital role you will support the GRC Governance / Policy & Audit team working closely with Technology teams to help ensure that GxP controls are in place, GxP deviations are managed and monitored, and security standards are met. The GxP Manager will assist in owning and maintaining GxP deviation records, performing GxP assessments, managing controlled documents, and supporting regulatory compliance efforts.

GxP Governance Leadership

• Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to information security governance, GxP deviation management, document management, audit commitments, and/or policy exception processes.

• Manage and own technology related GxP deviations, CAPA, and CAPA-EV records
• Manage GxP reporting and monitoring metrics for Technology/IT records
• Collaborate with record owners and QA to ensure timely record resolution
• Lead the identification and evaluation of risks associated with GxP deviation records.
• Identify and support new record owners across IT/Technology (e.g. office hours, ad-hoc meetings, document management support).
• Attend enterprise network meetings and Quality Forums as needed to represent the Technology / IT function .

• Recommend deviation management improvement strategies across Technology/IT.
• Collaborate with Quality, IT application, cybersecurity, and business teams to supervise and resolve identified risks and vulnerabilities associated with deviations and CAPA s.
• Lead and manage conducting CAPA applicability assessments, time studies, and related initiatives to identify impacts and improvement opportunities in IT systems, processes, and policies.
• Supervise, monitor, and report on the efficiency of existing GxP records, trends, and recommend improvements as needed.

• Ensure compliance with relevant industry standards and regulatory requirements (e.g., GxP, GDPR, SOX, NIST).
• Lead proactive measures to facilitate compliance, such as collaborating with partners to initiate periodic reviews
• Lead the preparation for audits and inspections by internal and external parties, providing documentation and evidence of IT GxP deviation management practices.
• Support the development and implementation of IT governance, risk, and compliance frameworks and continuous improvements.
• Support the development and implementation of IT governance, risk, and compliance policies as well as supporting documentation, and their continuous improvements.
• Track and monitor document reviews, and support document owners to ensure timely periodic review completion.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 2 years of IT GxP deviation management, IT quality management, IT auditing, or information security experience OR
• Master s degree and 8 to 10 years of IT GxP deviation management, IT quality management, IT auditing, or information security experience OR
• Bachelor s degree and 10 to 14 years of IT GxP deviation management, IT quality management, IT auditing, or information security experience OR
• Diploma and 14 to 18 years of IT GxP deviation management, IT quality management, IT auditing, or information security experience

Preferred Qualifications:

• Solid understanding of GxP deviation management , controlled document management, IT infrastructure & systems, and security standard methodologies.
• Ability to assess technical and business risk related to information systems.
• Excellent problem-solving, analytical, and communication skills.
• Ability to communicate complex GxP and risk concepts to non-technical partners.
• Familiarity with regulatory frameworks and compliance standards (e.g., GxP, GDPR, HIPAA, SOX).

• Proficiency with GxP deviation management tools, GRC (Governance, Risk, and Compliance) software, controlled document management tools enterprise organisational change tools, and security incident management tools.
• Experience with security controls related to networks, databases, and cloud environments.

• 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, budget, and PI plan successfully
• Ability to manage a team of Information Security experts
• Team oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills

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.