Head of Quality Assurance, Biotech & Compliance

Fate Therapeutics Inc.

San Diego (CA)

On-site

USD 250,000 - 280,000

Full time

17 hours ago
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Benefits offered by this job

Annual bonus
Equity
Benefits package

Job summary

Fate Therapeutics, Inc. seeks a Senior Director, Quality Assurance to lead the QA organization across GxP functions at the San Diego, CA headquarters.

The role blends pragmatic, phase-appropriate oversight with a strategic vision to scale as Fate grows. You will own the QMS, ensure inspection readiness, and partner with Clinical, CMC, Regulatory, and Supply Chain leaders to drive compliant product development and manufacturing.

Qualifications

  • Bachelor’s degree in life sciences with 10+ years of QA experience in pharma/biotech.
  • Deep cGxP expertise, GMP and GCP with knowledge of global regs.
  • Experience with biologics, gene therapy, or cell therapies across clinical to commercial.
  • Proven track record leading QA teams and scaling quality operations.
  • Experience supporting regulatory submissions and inspections.

Responsibilities

  • Develop and execute QA strategy aligned with regs while maintaining inspection readiness.
  • Lead QA organization across Quality Ops, Quality Systems, Validation, Supplier Quality, and Clinical Quality.
  • Oversee administration of the Quality Management System across all GxP activities.
  • Make strategic quality decisions shaping Fate's quality direction and business outcomes.
  • Ensure timely review of protocols, reports, risk assessments, and technical docs.
  • Maintain QA metrics and escalation processes for risk management.

Skills

GxP expertise
QA leadership
Regulatory inspections
Quality systems

Education

B.S. life sciences
Advanced degree preferred

Job description

Fate Therapeutics, Inc. seeks a Senior Director, Quality Assurance to lead the QA organization across GxP functions at the San Diego, CA headquarters.

The role blends pragmatic, phase-appropriate oversight with a strategic vision to scale as Fate grows. You will own the QMS, ensure inspection readiness, and partner with Clinical, CMC, Regulatory, and Supply Chain leaders to drive compliant product development and manufacturing.

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