Associate Director, Process Validation and Risk Management

Responsibilities

• Provide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs.
• Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch.
• Develop and implement risk management frameworks, tools, and processes in collaboration with Quality.
• Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks.
• Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state.
• Collaborate with Regulatory, CMC, Quality, Supply Chain, and Engineering to support commercialization and supply continuity.
• Contribute to authoring and reviewing regulatory filings and responses to health authorities.
• Provide guidance on raw material qualification strategies and support validation activities across internal and external manufacturing networks.

Requirements

• Degree in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or a related discipline.
• Minimum of 9+ years of relevant experience with a Ph.D., 11+ years with an M.S./M.A., or 14+ years with a B.S./B.A.
• Strong experience in biologics or vaccine manufacturing.
• Deep knowledge of process validation (PPQ/CPV) and MSAT or technical operations.
• Proven experience in technology transfer and commercialization.
• Expertise in quality risk management (ICH Q9) and regulatory expectations.
• Demonstrated leadership in matrixed or cross-functional team environments.
• Ability to travel 10-30% domestically and internationally.

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. Our mission is to protect humankind by developing vaccines for infections such as invasive pneumococcal disease, Group A Strep, and Shigella.