Senior Director, R&D GxP Audit Job at Amgen

Job Description

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

Job Responsibility

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
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
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
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
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

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
at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Nice to have

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 we offer

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

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Senior Director, R&D GxP Audit

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