Senior Director, R&D GxP Audit

Amgen

Senior Director, R&D GxP Audit leading global audit strategy and compliance at Amgen. Responsible for overseeing audits and ensuring adherence to GxP regulations.

Posted 6/3/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $199,782 - $270,294 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality AssuranceGxP regulationsGCPGLPGVP/PVrisk managementCAPA systemsaudit programsdata integrityvendor oversight

Soft Skills

leadershipexecutive communicationinfluencingteam managementproject managementresource allocationstrategic planningcollaborationproblem-solvingcontinuous improvement

Certifications

Doctorate degreeMaster’s degreeBachelor’s degreeMBAMS in OperationsMS in Engineering