Information Security GxP Specialist

Join Amgen’s Mission of Serving Patients

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

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

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

Information Security GxP Specialist

What you will do

Let’s do this. Let’s change the world. In this lead 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 Specialist will assist in owning and maintaining GxP deviation records, performing GxP assessments, managing controlled documents, and supporting regulatory compliance efforts.

Roles & Responsibilities:

GxP Governance Leadership:

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

GxP Deviation and CAPA Management:

• 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

• Assist in 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 as needed to represent the Technology / IT function.

GxP Deviation Monitoring and Improvements:

• 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.

• Assist in 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.

Governance and Regulatory Support:

• Ensure compliance with relevant industry standards and regulatory requirements (e.g., GxP, GDPR, SOX, NIST).

• Assist in proactive measures to facilitate compliance, such as collaborating with stakeholders to initiate periodic reviews

• Assist in 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The GxP security professional we seek is collaborative and action-oriented with these qualifications.

Basic Qualifications:

• 5+ years of experience in IT GxP deviation management, IT quality management, IT auditing, or information security.

• Hands-on experience with deviation management tools and associated frameworks (e.g., ISO 27001, NIST, COBIT).

• Master’s degree and 4 to 6 years of information technology, Cybersecurity, Risk Management, or a related field experience OR

• Bachelor’s degree and 6 to 8 years of information technology, Cybersecurity, Risk Management, or a related field experience OR

• Diploma and 10 to 12 years of information technology, Cybersecurity, Risk Management, or a related field experience

Preferred Qualifications:

• Good 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 collaborators.

• Familiarity with regulatory frameworks and compliance standards (e.g., GxP, GDPR, HIPAA, SOX).

Technical Knowledge:

• Proficiency with GxP deviation management tools, GRC (Governance, Risk, and Compliance) software, controlled document management tools, enterprise change management tools, and security incident management tools.

• Experience with security controls related to networks, databases, and cloud environments.

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

• 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.

Apply now and make a lasting impact with the Amgen team.

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.