Senior Director, R&D GxP Audit

🕒 June 3

🇺🇸 United States – Remote

💵 $199.8k - $270.3k / year

⏰ Full Time

🟠 Senior

👔 Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Lead the global strategy, execution, and continuous improvement of the internal and external audit program supporting the Research & Development (R&D) Quality organization. • Provide independent assurance that systems, processes, vendors, and clinical trial operations comply with applicable GxP regulations, internal standards, and industry expectations. • Oversee risk-based audit programs across GCP, GLP, Pharmacovigilance, computerized systems, data integrity, and vendor oversight. • Partner closely with R&D Quality leadership, Global Development, Safety, Regulatory Affairs, and external partners to strengthen compliance, inspection readiness, and proactive risk management. • Develop and execute a global, risk-based GxP audit strategy aligned to quality and portfolio priorities. • Build and lead a high-performing audit organization.

🎯 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 • 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.

🏖️ Benefits

• 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 • 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.