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

Role: Executive Director of GCP QA leading global clinical quality assurance for late-stage oncology programs at Revolution Medicines, focusing on GCP, GLP, and pharmacovigilance compliance across Phase 2/3 studies. Responsibilities: develop and execute QA strategies, oversee audit and inspection activities, manage vendor and CRO quality, ensure inspection readiness, and advise senior leadership on regulatory and quality risks. Requirements: advanced degree in life sciences, at least 15 years in pharma/biotech with 10+ years in GCP QA leadership, extensive experience managing regulatory inspections (FDA, EMA), supporting late-stage clinical development, and working with global authorities. High-Value: oncology, late-stage clinical trials, GCP, GLP, pharmacovigilance, regulatory inspections, global QA leadership, vendor oversight, risk management, continuous improvement, digital quality tools. WorkSetup: based in Redwood City, CA, with up to 15% travel; role demands fast-paced, dynamic environment and cross-functional collaboration.