Senior Director, Quality Assurance

Fate Therapeutics is looking for an experienced and hands-on Senior Director, Quality Assurance to lead our Quality organization across GxP functions. You will own the Quality Management System (QMS), ensure our clinical programs and supply chain are inspection-ready, and serve as a strategic partner to Clinical, CMC, Regulatory, and Supply Chain leadership. This is a high-visibility role for a leader who can balance pragmatic, phase-appropriate quality oversight with the strategic vision needed to scale as we grow.

This is a full-time exempt position located at our corporate headquarters in San Diego, CA.

• Develop and execute Fate’s Quality Assurance (QA) strategy in alignment with corporate objectives, regulatory requirements, and industry best practices, while maintaining inspection readiness.
• Lead, develop, and scale a high-performing QA organization spanning Quality Operations, Quality Systems, Validation, Supplier Quality, and Clinical Quality.
• Own and oversee administration of Fate’s Quality Management System across all GxP activities.
• Make strategic and operational quality decisions that shape Fate’s quality direction and business outcomes.
• Partner across programs, functions, and external vendors to ensure projects are planned and executed in accordance with company processes and industry best practices.
• Maintain accountability for GxP compliance, quality systems, and regulatory inspection outcomes.
• Provide QA and compliance expertise across product and process development, manufacturing, testing, qualification/validation, supply, and clinical trial execution.
• Review and approve protocols, reports, risk assessments, and supporting technical justification documents, as required.
• Revise, review, and approve applicable documents, SOPs, and policies within Fate’s eDMS.
• Serve as an authorized contact for GMP audits and health authority inspections.
• Review documentation, quality events, and reports in a timely manner, when needed, escalating and supporting resolution of risk-based issues.
• Develop and report quality metrics that identify compliance trends, risk areas, and mitigation plans.
• Maintain current knowledge of regulations, corporate policies, industry standards, and best practices to ensure ongoing QA and QMS compliance.
• Advance QA capabilities by building the technical expertise and compliance systems needed to meet current and emerging regulatory requirements.
• Establish continuous learning and improvement programs that support team engagement, development, and performance.
• Promote a company-wide culture of safety, quality, accountability, and responsible decision-making.
• Perform other duties as required.

• B.S. degree in life sciences with at least 10 years of relevant and progressive Quality Assurance experience in the pharmaceutical or biotechnology industry; advanced degree preferred.
• Deep cGxP expertise, particularly GMP and GCP, with strong understanding of applicable global regulations, standards, and quality expectations.
• Technical and regulatory experience with biologics, gene therapy, or cell therapy across clinical development and commercial stages.
• Demonstrated experience supporting clinical and commercial products, scaling quality operations, streamlining quality systems, and maintaining global compliance.
• Strong knowledge of QA principles, industry practices, GMP operations, and quality systems, including deviations, CAPAs, change control, and validation concepts for drug substance and drug product manufacturing.
• Proven ability to lead high-performing QA teams, manage people effectively, and develop organizational capability.
• Experience managing third-party contractors and vendors in regulated environments.
• Experience supporting regulatory submissions,…