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New · posted Oct 15

Fate Therapeutics · Biotechnology

Senior Director, Quality Assurance

  • San Diego, CA
  • On-site
  • Full-time
  • Director
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Pay$250K–$280Ka year · employer provided
EmploymentFull-time
LocationSan Diego, CAOn-site
LevelDirector
FunctionQuality AssuranceQuality
Deadline

Open until filled

The role

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.

What you need

  • 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.

    • Skills named in this posting

    What you'll do

  • 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.

    • Pay and benefits

    $250,000 – $280,000 a year

    Employer provided
    How this compares

  • 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.

    • Annual bonus

    • Equity

    • Generous benefits package

    Where you'll work

    San Diego, CAOn-siteOpen in Maps (opens in a new tab)

    More jobs in San Diego, CA
    Equal opportunity, accessibility and legal noticesFate Therapeutics's statements, word for word

    Equal Employment Opportunity

    Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

    Privacy Notice

    To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.

    About Fate Therapeutics, Inc.

    Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

    ⚠️ Recruitment Fraud Alert

    Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.

    Here are a few things to be aware of to help identify recruitment fraud:

    - Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.

    - At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.

    - We will only ask for personal information when applying for a position via our Careers page or thereafter.

    - At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.

    - We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews.

    Please exercise caution. If something feels off about your interactions, we encourage you to contact us at [email protected] to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.

    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.

    Job intelligence

    The context around this role

    Live data · October 15, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 27% above the US median for Quality Assurance roles at this level.

    This roleEmployer provided

    $250,000 to $280,000 a year

    Director roles in California26 roles publishing pay

    Middle half $197,500 to $241,000, median $213,500

    Director roles in the US102 roles publishing pay

    Middle half $186,500 to $231,375, median $209,250
    Annual base pay
    Annual base payLowMedianHigh
    This role$250,000—$280,000
    California$197,500$213,500$241,000
    All US$186,500$209,250$231,375

    This role: Fate Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Quality Assurance

    The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Fate Therapeutics's own promotion track.

    1. Earlier

      Associate & Specialist

      Often: Quality Engineer · Quality Technician

      $79K median227 open

    2. Earlier

      Senior & Principal

      Often: Quality Engineer · Senior Quality Engineer

      $123K median353 open

    3. One step back

      Manager

      Often: Manager, Quality Assurance · Quality Manager

      $153K median136 open

    4. This role

      Director

      Often: Director, Quality · Associate Director, Clinical Quality Assurance

      $209K median114 open

    5. Next step

      VP & Executive

      Often: Vice President, Quality Assurance · AVP

      $302K median15 open

    Career resources on Quality Assurance

    Skills DNA

    What this role leans on

    How many of the posting's 4 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    GMP and compliance: 3 linesLab testing and methods: 1 lineDocumentation and SOPs: 1 lineInvestigations and CAPA: 1 lineValidation and qualification: 2 linesRegulatory submissions: 2 linesQuality systems and risk: 3 linesCollaboration and leadership: 3 linesGMPLab testingDocumentationInvestigationsValidationSubmissionsQuality systemsTeamwork
    • GMP and compliance3
    • Quality systems and risk3
    • Collaboration and leadership3
    • Validation and qualification2
    • Regulatory submissions2
    • Lab testing and methods1
    • Documentation and SOPs1
    • Investigations and CAPA1

    Regulatory intelligence

    The rules behind this role

    Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

    From Regulatory News

    Manufacturing and quality coverage for this profession

    Company hiring pulse

    Fate Therapeutics on Regulatory Jobs

    2
    Open roles
    2
    Distinct roles
    1
    Locations
    See all 2 Fate Therapeutics roles

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      Senior Director, Quality Assurance at Fate Therapeutics — San Diego, CA | Regulatory Jobs