Lab Compliance Manager

Role: The Lab Compliance Manager oversees GMP compliance within Vaxcyte's Analytical Development labs supporting vaccine CMC programs. Objectives include ensuring laboratory adherence to quality policies, facilitating transition to GMP operations for Phase I/II clinical testing, and maintaining readiness for regulatory inspections. Responsibilities encompass managing sample handling processes, authoring and implementing SOPs, supporting change control and deviation management, maintaining qualification and calibration records, and ensuring data integrity across paper and electronic systems like Benchling. The role also involves staff training, supervising the Sample Management Specialist, and collaborating with QA to uphold inspection readiness. Qualifications: Bachelor's in life sciences, 8+ years in biopharma quality or analytical labs, with a solid grasp of GMP/GLP principles, controlled document authoring, equipment qualification, and data integrity standards. Preferred skills include experience supporting early-stage biologics or vaccine programs, familiarity with electronic lab systems and 21 CFR Part 11 compliance, and prior involvement in audits or regulatory inspections. HighValue: Focus on vaccine CMC, GMP compliance, Phase I/II support, regulated lab environment, and cross-functional collaboration with QA and analytical teams. WorkSetup: Hybrid in San Carlos, CA, minimum 3 days onsite.