Executive Director Quality Assurance, External Manufacturing

Role: Executive Director, Quality Assurance, External Manufacturing at Vaxcyte, overseeing global external manufacturing quality functions within a highly outsourced, vaccine-focused environment. Responsibilities: lead external GMP quality performance across CDMOs, drive compliance, supply continuity, risk management, and inspection readiness; govern external quality metrics and investigations; support technology transfer and lifecycle management; build and develop a high-performing external QA team; influence cross-functional stakeholders and represent QA in executive forums. Requirements: BS/BA with 16+ years in QA within biopharma, extensive GMP, FDA, and ICH expertise; proven leadership in external manufacturing, CDMO oversight, and regulatory inspections; experience in vaccine or biologics manufacturing preferred; strong risk management, strategic influence, and organizational development skills. HighValue: vaccines, biologics, external manufacturing, global regulatory compliance, inspection readiness, risk-based quality oversight, leadership in outsourced models. WorkSetup: hybrid San Carlos, CA (minimum 3 days onsite); salary $300K-$350K plus benefits and equity.