Director Product Quality Leader

AstraZeneca

Santa Monica, CA, US
Base: $167,595.20 - $251,392.80; bonus/equity: eli...
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Cell & gene therapy leadership experience
Global cgmp regulatory compliance expertise
Cmc section authoring for ind/bla submissions
** AstraZeneca is seeking a Director Product Quality Leader for their Santa Monica and Tarzana locations, responsible for overseeing the quality strategy and lifecycle management of cell therapy products. The ideal candidate will have extensive experience in biotechnology, particularly in cell and gene therapy, with a strong focus on regulatory compliance and cross-functional collaboration. **

Job Summary

  • This role serves as the single voice of Quality for autologous, allogeneic, and in-vivo cell therapy products from clinical stage through commercialization.
  • The leader is responsible for developing the overall Product Quality Strategy and maintaining lot release and stability specifications for advanced modalities.
  • Candidates must have a demonstrated record of authoring CTD sections for global filings including INDs, BLAs, and MAAs while managing responses to health authority queries.

Matching Summary

Match Score: 75

** AstraZeneca is seeking a Director Product Quality Leader for their Santa Monica and Tarzana locations, responsible for overseeing the quality strategy and lifecycle management of cell therapy products. The ideal candidate will have extensive experience in biotechnology, particularly in cell and gene therapy, with a strong focus on regulatory compliance and cross-functional collaboration. **

Salary

Base: $167,595.20 - $251,392.80; Bonus/Equity: Eligible for short-term incentives and equity-based awards; Benefits: Qualified retirement programs, paid time off, health, dental, and vision coverage

Skills & Requirements

Must-have

  • Cell & Gene Therapy leadership experience
  • Global cGMP regulatory compliance expertise
  • CMC section authoring for IND/BLA submissions
  • Viral vector and gene-edited product knowledge
  • Process tech transfer and analytical method validation

Nice-to-have

  • Strategic thinking in matrixed environments
  • Cross-functional collaboration skills
  • Ability to influence without direct authority
  • Experience with platform approaches for specifications
  • Subject Matter Expertise for health authority inspections

Key Requirements

  • Bachelor's or Advanced degree (MS/PhD) in Life Sciences or Engineering
  • 10+ years in biotech/biopharma industry
  • 3-5 years in Cell & Gene Therapy leadership role
  • Expertise in FDA, EMA, and ICH regulations
  • Proven success in fast-paced matrixed environments

Work Rights

Not specified

Tailored Resume

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