Manager, Quality Assurance, Compliance

Summary:

Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is responsible for providing day-to-day operational oversight governance and strategic oversight of key Quality System processes, with a primary focus on leading Change Control governance and deviation/investigation oversight review board leadership. This role insures consistent, risk-based decision making, inspection readiness, and cross-functional accountability across quality systems. The Manager acts as an operational backbone a governance leader for cross-functional quality processes, proactively identifying systemic risks, ensuring procedural compliance, driving performance through KPIs, and presenting quality system health and trends through Management Review.

Essential Functions:

• Change Control Governance & Board Leadership
  • Lead and coordinate the Change Control Review Board (CCRB), including agenda development, facilitation, quorum confirmation, and documentation of decisions.
  • Perform pre-CCRB QA review of Change Requests to ensure completeness, clarity, and appropriate risk classification prior to board review.
  • Verify alignment of Change Requests with applicable SOPs, including confirmation of CCRB-required versus discretionary changes.
  • Provide QA authority on change classification, risk assessment, impact evaluation, and implementation strategy.
  • Own CCRB performance metrics, including cycle time, risk categorization trends, backlog, and recurring impact areas. Present trends and risk signals to senior leadership and during Management Review.
• Deviation and Investigation Governance
  • Lead or co-lead Deviation Review Boards to ensure consistent, risk-based decision making.
  • Ensure appropriate classification (minor, major, critical) and scientifically sound investigations.
  • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
  • Ensure linkage between deviations, CAPA, and change controls to prevent recurrence and address systemic risk.
• Quality Metrics and Management Review
  • Own development, maintenance, and reporting of Quality System KPIs related to Change Control, Deviations, Investigations, and CAPA.
  • Perform routine trend analysis and signal detection to identify emerging compliance risks.
  • Prepare and present Quality System performance data during Management Review.
• Inspection Readiness and Regulatory Support
  • Serve as Subject Matter Expert (SME) for Change Control and Deviation processes during regulatory inspections and audits.
  • Support preparation of audit responses and ensure timely and compliant closure of observations.
  • Maintain processes in a continuous state of inspection readiness.

Requirements: 

• Bachelor’s degree in Life Sciences or a related field.
• 5+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industry. Other combinations of education and/or experience may be considered.
• Experience leading cross-functional governance boards strongly preferred.
• Strong understanding of ICH Q10, risk management principles, and inspection expectations.
• Experience with electronic Quality Management Systems (eQMS) strongly preferred.
• In-depth knowledge of cGMP regulations.
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
• Strong interpersonal and communication skills to work effectively across functions and with external partners.