Cell Therapy Quality Strategy Director

AstraZeneca GmbH; Santa Monica (CA); On-site; USD 168,000 - 251,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Retirement programs

Paid time off

Health, dental, and vision coverage

Job summary

AstraZeneca GmbH in Santa Monica, CA is seeking a Cell Therapy Product Quality Leader to own end-to-end quality strategy for autologous, allogeneic, and in-vivo cell therapies from clinical to commercial stages.

This role partners with Regulatory, Process Development, Analytical Sciences, Supply Chain, and other functions to ensure CGMP compliance, product stability, and lifecycle management, including authoring CMC sections and supporting health authority inspections.

Qualifications

• Bachelor’s or MS/PhD in Life Sciences or Engineering.
• 10+ years in biotech/biopharma with CGT or biologics leadership.
• Deep understanding of global cGMP regs (FDA, EMA, ICH).
• Authoring CTD sections for IND, BLA/MAA, and post-approval submissions.
• Expertise in analytical method validation, process development, tech transfer, and viral vectors.
• Experience in designing product & process control and comparability strategies.
• Ability to articulate complex technical concepts to cross-functional and regulatory audiences.
• Success in fast-paced, matrixed environments with stakeholder influence.

Responsibilities

• Serve as the Quality representative on the CMC team and lead the PQT sub-team.
• Be the single voice of Quality liaising with the CMC Program Lead.
• Develop and implement the overall Product Quality Strategy and phase-appropriate control strategies.
• Own and maintain lot release and stability specifications for CGT modalities.
• Manage the full specification lifecycle from clinical to post-approval.
• Support design and execution of analytical comparability studies.
• Support process transfer and analytical method transfer protocols.
• Oversee the stability program with Global Stability collaboration.
• Oversee annual product reviews for commercial products.
• Maintain the Product Quality Risk Register.
• Work cross-functionally to develop platform approaches for specs and stability.
• Author and review CMC sections for global filings; respond to health authority queries.
• Stay current on emerging processes & analytical technologies and regulatory expectations.
• Partner with Process Development, Analytical Sciences, Supply Chain, Quality, Regulatory, Program Management.
• Act as SME during health authority inspections (FDA, EMA).
• Review major process changes for product safety and efficacy.

Skills

Quality leadership

CMC liaison

Regulatory knowledge

GMP / cGMP knowledge

Product quality strategy

Tech transfer

Analytical methods

Cross-functional collaboration

Inspection readiness

Education

Life sciences or engineering degree

MS/PhD preferred

Job description

AstraZeneca GmbH in Santa Monica, CA is seeking a Cell Therapy Product Quality Leader to own end-to-end quality strategy for autologous, allogeneic, and in-vivo cell therapies from clinical to commercial stages.

This role partners with Regulatory, Process Development, Analytical Sciences, Supply Chain, and other functions to ensure CGMP compliance, product stability, and lifecycle management, including authoring CMC sections and supporting health authority inspections.