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Vaxcyte, a clinical-stage vaccine innovation company, is seeking a Lab Compliance Manager to join its Global Analytical organization in San Carlos, CA. The role serves as the primary compliance partner for the Analytical Development (AD) laboratories, which support CMC programs through method development, method transfer, and characterization testing activities that enable regulatory filings.
The Lab Compliance Manager will operationalize established quality policies and procedures within the lab setting, working collaboratively with Quality Assurance (QA). A key responsibility is guiding the AD laboratories through a transition from non-GMP to GMP-compliant operations to enable Phase I/II early clinical release and stability testing QC laboratory capabilities.
Key responsibilities include: directly managing the Sample Management Specialist and overseeing sample receipt, logging, storage, distribution, and disposition activities; partnering with QA to translate quality policies into laboratory-specific SOPs, work instructions, and forms; supporting implementation of laboratory quality processes including change control, deviation management, OOS/OOT investigations, and CAPA; implementing QA-defined data integrity requirements and ensuring ALCOA+ compliance across paper and electronic records (Benchling, instrument software); maintaining method qualification records and lifecycle tracking; overseeing equipment qualification (IQ, OQ, PQ) and calibration/preventive maintenance schedules; partnering with ASAT for reference standards and critical reagents oversight; coordinating role-based laboratory training and maintaining training records; and ensuring documentation and daily practices remain inspection-ready, serving as the lab-level point of contact during internal audits and regulatory inspections.
The role reports to the Director of Infrastructure and Capabilities in Global Analytical and requires a solid understanding of laboratory GMP requirements and regulatory expectations for Phase I/II programs.
