Associate Director, Process Validation and Risk Management

Role: Associate Director of Process Validation and Risk Management, focusing on leading and coordinating process validation and risk mitigation activities across Vaxcyte’s vaccine manufacturing pipeline to ensure regulatory compliance and commercial readiness. Responsibilities: develop and execute validation strategies (PPQ, CPV, lifecycle validation), lead risk assessments, support lifecycle management, and collaborate with cross-functional teams including Quality, Regulatory, CMC, Supply Chain, and External Partners. Oversee validation of processes, systems, and facilities; contribute to regulatory filings; and support deviation investigations. Requirements: Degree in Chemical, Biochemical Engineering, Chemistry, or related; 9+ years (Ph.D.), 11+ (M.S.), or 14+ (B.S.) in biologics/vaccine manufacturing, with experience in process validation, tech transfer, quality risk management (ICH Q9), and regulatory expectations. Preferred skills include leadership in matrixed environments, strategic problem-solving, stakeholder engagement, and innovative mindset. HighValue: vaccine biologics, process validation (PPQ, CPV), lifecycle management, risk assessment, regulatory compliance, global manufacturing networks. Collaboration with regulatory, quality, and manufacturing teams is central. Location: San Carlos, CA or North Carolina; travel 10-30% domestically and internationally.