Manager, Quality Assurance, Compliance

Vaxcyte•San Carlos, CA

6h•$151,000 - $176,000•Hybrid

About The Position

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.

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.
Strong understanding of ICH Q10, risk management principles, and inspection expectations.
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.

Nice To Haves

Experience leading cross-functional governance boards strongly preferred.
Experience with electronic Quality Management Systems (eQMS) strongly preferred.

Responsibilities

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.
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.
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.
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.