Executive Director, GxP Quality and Compliance
Listed on 2026-09-14
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Healthcare
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Quality Assurance - QA/QC
Role:
Senior GxP Quality & Compliance Executive leading global regulatory compliance strategies for clinical and commercial oncology products, including novel RAS-targeted therapies in development.
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.
RequirementsPhD, 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.
High Valueexperience with clinical and commercial GxP compliance, inspection readiness, biotech/oncology focus, global regulatory engagement, and digital compliance tools.
Work Setupon-site in Redwood City, CA; up to 15% travel.
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