Senior Director, R&D GxP Audit

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

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

Senior Director, R&D GXP Audit

What you will do

Let’s do this! Let’s change the world! The Senior Director, R&D GxP Audit will lead the global strategy, execution, and continuous improvement of the internal and external audit program supporting the Research & Development (R&D) Quality organization. This leader is responsible for providing independent assurance that systems, processes, vendors, and clinical trial operations comply with applicable GxP regulations, internal standards, and industry expectations. The role oversees risk-based audit programs across GCP, GLP, Pharmacovigilance, computerized systems, data integrity, and vendor oversight. This position partners closely with R&D Quality leadership, Global Development, Safety, Regulatory Affairs, and external partners to strengthen compliance, inspection readiness, and proactive risk management. The ideal candidate brings deep GXP auditing expertise, strong regulatory knowledge (GCP/GVP), leadership capability, and the ability to influence quality culture across a global organization

Key Responsibilities

Audit Strategy & Leadership

• Develop and execute a global, risk-based GxP audit strategy aligned to quality and portfolio priorities.

• Lead internal, external, and supplier audit programs across R&D and supporting functions.

• Serve as a strategic advisor to the Head of R&D Quality on compliance trends, systemic risks, and assurance strategies.

• Build and lead a high-performing audit organization with strong technical and leadership capability.

Audit Program

• Oversee audits of clinical trial processes, pharmacovigilance systems, laboratories, quality systems, and supporting functions.

• Ensure audits assess both compliance to regulations and effectiveness of quality management systems.

• Drive consistency in audit methodology, planning, execution, reporting, and follow-up globally.

• Evaluate third-party quality systems, regulatory history, data integrity controls, and operational capability.

• Support qualification, ongoing oversight, escalation, and remediation of critical suppliers.

Risk Management & Governance

• Use quality risk management principles and data analytics to prioritize audits based on business criticality, compliance history, inspection outcomes, and emerging risks.

• Present audit trends, systemic observations, and risk insights to executive leadership and governance forums.

• Maintain enterprise visibility to CAPA status, recurring issues, and risk mitigation effectiveness.

• Escalate significant compliance risks appropriately and timely.

• Provide audit intelligence and readiness assessments to support health authority inspections.

CAPA & Continuous Improvement

• Ensure audit observations are clearly documented, risk-ranked, and linked to sustainable CAPA plans.

• Monitor effectiveness of corrective and preventive actions through follow-up activities.

• Identify recurring themes and drive enterprise improvement initiatives.

• Continuously modernize audit tools, processes, and auditor capabilities in partnership with Global Quality

Talent & Capability Development

• Recruit, develop, and mentor audit professionals with expertise across GCP, GLP, GMP, PV, and systems auditing.

• Promote a culture of coaching, technical excellence, and continuous learning.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic leader we seek is an individual with these qualifications

Basic Qualifications:

• Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR

• Master’s degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR

• Bachelor’s degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry

In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• Advanced degree (MBA, MS in Operations/Engineering, or similar).

• Deep knowledge of GxP regulations including GCP, GLP, GVP/PV, and quality systems.

• Demonstrated success leading complex internal and external audit programs.

• Strong knowledge of risk management, CAPA systems, supplier oversight, and inspection readiness.

• Strong executive communication and influencing 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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

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

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

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.