Senior Director, QA & QMS Strategy (GxP)

Fate Therapeutics, Inc.; San Diego (CA); On-site; USD 250,000 - 280,000; Full time

Job summary

Fate Therapeutics, Inc. is seeking an experienced Senior Director, Quality Assurance to lead the QA organization across GxP functions from its San Diego headquarters.

The role owns the QMS, ensures inspection readiness for clinical programs and supply chain, and partners with Clinical, CMC, Regulatory, and Supply Chain leadership. The candidate will drive QA strategy, oversee Quality Operations, Quality Systems, Validation, Supplier Quality, and Clinical Quality, and guide risk-based

Qualifications

• Bachelor of Science in life sciences with 10+ years of QA experience.
• Deep cGxP expertise including GMP and GCP.

Responsibilities

• Develop and execute QA strategy aligned with objectives and regulatory requirements, maintaining inspection readiness.
• Lead QA organization across Quality Operations, Quality Systems, Validation, Supplier Quality, and Clinical Quality.
• Own and oversee administration of the Quality Management System across all GxP activities.
• Review and approve protocols, reports, risk assessments, and supporting technical documentation.
• Maintain accountability for GxP compliance and regulatory inspection outcomes.
• Promote continuous improvement and build QA capabilities to meet evolving regulatory standards.

Job description

Fate Therapeutics, Inc. is seeking an experienced Senior Director, Quality Assurance to lead the QA organization across GxP functions from its San Diego headquarters.

The role owns the QMS, ensures inspection readiness for clinical programs and supply chain, and partners with Clinical, CMC, Regulatory, and Supply Chain leadership. The candidate will drive QA strategy, oversee Quality Operations, Quality Systems, Validation, Supplier Quality, and Clinical Quality, and guide risk-based