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Jobs · Quality Assurance · California

Manager, Quality Assurance, Compliance

Vaxcyte · San Carlos, CA · 3 wk ago
Quality AssuranceFull-time

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.
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
    • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).

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