B.S. in life sciences with 10+ years in Quality Assurance in pharma/biotech; advanced degree preferred.
Expertise in cGxP, especially GMP and GCP, with a solid grasp of global regulations.
Technical experience with biologics, gene therapy, or cell therapy in clinical and commercial stages.
Proven track record in scaling quality operations and maintaining global compliance.
Strong knowledge of QA principles, GMP operations, and quality systems like CAPAs and change control.
Experience managing third-party contractors in regulated environments.
Excellent collaboration and communication skills, with a knack for aligning stakeholders.
Responsibilities
Develop and execute the QA strategy aligned with corporate goals and regulatory standards.
Lead and scale a high-performing QA organization across various quality functions.
Oversee the Quality Management System for all GxP activities.
Make strategic quality decisions that influence business outcomes.
Collaborate with programs and external vendors to ensure compliance with best practices.
Maintain accountability for GxP compliance and regulatory inspection outcomes.
Provide QA expertise across product development, manufacturing, and clinical trials.
Benefits
Generous benefits package including annual bonus and equity options.
Opportunity to work in a high-visibility role at a growing company.
Engagement in a culture of safety, quality, and accountability.
Professional development opportunities to advance QA capabilities.
Full Job Description
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.
Responsibilities
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.
Qualifications
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, 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.
Working Conditions & Physical Requirements
Travel may be required (up to 20%).
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
Compensation
The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
The anticipated salary range for this role is $250,000 - $280,000.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
About Fate Therapeutics, Inc.
Fate Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of programmed cellular immunotherapies for cancer and immune disorders. The company's lead product candidate, FT516, is an off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. Fate Therapeutics' pipeline also includes FT596, a multi-antigen targeting NK cell cancer immunotherapy, and FT819, a CAR T-cell therapy for the treatment of acute myeloid leukemia (AML) and B-cell lymphoma. The company was founded in 2007 and is headquartered in San Diego, California.
