Executive Director, GCP QA (Good Clinical Practice, Quality Assurance)

Revolution Medicines seeks an Executive Director of GCP QA to lead global quality assurance strategy across clinical oncology development programs. This senior leadership role ensures regulatory compliance, oversees a QA team, manages contract research organizations, and advises executives on clinical quality risk and regulatory readiness.

Responsibilities

• Develop and execute global GCP QA strategy aligned with regulatory requirements and company objectives
• Serve as Clinical QA Lead for Phase 2/3 oncology studies and represent QA in governance forums
• Oversee end-to-end quality oversight including protocols, TMF readiness, and data integrity controls
• Lead GCP audit and inspection activities across sites, vendors, and internal processes
• Interface with regulatory authorities and lead inspection strategy and preparation activities

Requirements

• Extensive experience in GCP QA leadership within clinical development
• Deep knowledge of FDA, EMA, ICH regulatory requirements and inspection processes
• Proven track record managing QA teams and cross-functional clinical programs
• Experience with risk-based quality management (RBQM) frameworks and systems
• Strong background in audit, inspection readiness, and regulatory strategy
• Demonstrated vendor and CRO governance and performance management expertise