Senior Director, R&D GxP Audit

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

Requirements

• 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 mus

Benefits

Additional Information

Career Category Quality Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. 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

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