Executive Director, GxP Quality and Compliance

Role: Senior GxP Quality & Compliance Executive leading global regulatory compliance strategies for clinical and commercial oncology products, including novel RAS-targeted therapies in development. Responsibilities: develop and execute enterprise-wide GxP compliance programs, oversee inspection readiness, manage quality systems, risk mitigation, and supplier oversight; collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, and Quality Assurance; advise senior leadership on compliance risks and regulatory interactions; support growth initiatives like product launches and market expansion. Requirements: PhD, MS, or equivalent in life sciences; 15+ years in GxP Quality/Compliance within biotech/pharma, with 8+ years in senior leadership roles overseeing global compliance; extensive knowledge of FDA, EMA, ICH, and other international GxP requirements; proven success in regulatory inspections and building compliance frameworks. HighValue: experience with clinical and commercial GxP compliance, inspection readiness, biotech/oncology focus, global regulatory engagement, and digital compliance tools. WorkSetup: on-site in Redwood City, CA; up to 15% travel.