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.

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.

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.

Senior Director, R&D GxP Audit

Key skills