Senior Director, Quality Assurance

Fate Therapeutics•San Diego, CA

26d•Onsite

About The Position

Fate Therapeutics is seeking an experienced, hands-on Senior Director, Quality Assurance to lead its Quality organization across GxP functions. The role owns the Quality Management System (QMS), ensures clinical programs and the supply chain are inspection-ready, and serves as a strategic partner to Clinical, CMC, Regulatory, and Supply Chain leadership. The position balances pragmatic, phase-appropriate quality oversight with the strategic vision needed to scale as the company grows. This is a full-time exempt position located at Fate Therapeutics’ corporate headquarters in San Diego, California. Travel may be required, up to 20%. The role may involve extended periods of sitting and standing, vision to monitor, and moderate noise levels. The anticipated salary range is $250,000–$280,000. The salary offer will be based on factors including level, experience, qualifications, internal equity, and location. Fate offers an annual bonus, equity, and a generous benefits package.

Requirements

B.S. degree in life sciences.
At least 10 years of relevant and progressive Quality Assurance experience in the pharmaceutical or biotechnology industry.
Deep cGxP expertise, particularly GMP and GCP, and a 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, commercial product approvals, and regulatory inspections.
Strong collaboration, team-building, communication, and organizational skills, with the ability to align stakeholders around plans and strategies.
Sound judgment, creative problem-solving, negotiation, and conflict-resolution skills.
Ability to manage competing priorities in a fast-paced, dynamic environment while driving projects forward and meeting deliverables.

Nice To Haves

Advanced degree.

Responsibilities

Develop and execute the 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 the Quality Management System across all GxP activities.
Make strategic and operational quality decisions that shape the company’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 and 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 the company’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 technical expertise and compliance systems 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.