Lab Compliance Manager
Vaxcyte · San Carlos, CA
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Role summary
Vaxcyte seeks a Lab Compliance Manager to oversee compliance operations for its Analytical Development laboratories in San Carlos, California. The role involves managing sample handling processes, developing laboratory-specific procedures aligned with GMP requirements, and supporting the transition to a Phase I/II clinical-stage QC laboratory. The position reports to the Director of Infrastructure and Capabilities and directly supervises a Sample Management Specialist.
What they're looking for
- Solid understanding of laboratory GMP requirements and regulatory expectations
- Experience translating quality policies into laboratory-specific standard operating procedures
- Knowledge of data integrity principles, ALCOA+ compliance, and electronic laboratory systems
- Proficiency with quality processes including change control, deviations, and CAPA management
- Direct supervisory or team management experience
- Familiarity with Phase I/II clinical program requirements
What you'll be doing
- Manage Sample Management Specialist with oversight of sample receipt, logging, storage, and disposition activities
- Author and maintain laboratory-level controlled documents in collaboration with Quality Assurance
- Implement quality processes including change control, deviation management, and investigations aligned with regulatory frameworks
- Ensure staff compliance with ALCOA+ principles across paper and electronic records including Benchling systems
- Support sample management during high-volume periods and guide lab transition to GMP-compliant operations
Privacy & handoff
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