Lab Compliance Manager

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: Vaxcyte is seeking a hands-on and detail-oriented Lab Compliance Manager to join our Global Analytical organization in San Carlos, CA. The Analytical Development (AD) laboratories within Global Analytical support Vaxcyte's CMC programs by performing method development, supporting method transfer, and executing various characterization testing activities that enable regulatory filings. This role will serve as the primary compliance partner for the AD laboratories, working collaboratively with Quality Assurance (QA), to operationalize established quality policies and procedures within the lab setting. Additionally, along with ensure the AD labs are aligned with Vaxcyte Quality requirements, the individual will be key in supporting an ongoing effort to evaluate and enhance the AD laboratories to enable operation as a Phase I/II early clinical release and stability testing QC laboratory. This requires an individual with a solid understanding of laboratory GMP requirements who can help guide lab personnel through the transition from a non-GMP to a GMP-compliant operating environment. The Lab Compliance Manager will directly manage the Sample Management Specialist and will report to the Director of Infrastructure and Capabilities in Global Analytical. Essential Functions: • Directly manage the Sample Management Specialist, providing day-to-day oversight of sample receipt, logging, storage, distribution, and disposition activities to ensure compliance with approved SOPs, chain-of-custody requirements, and GDP standards. • Support the Sample Management process by stepping in and managing samples during times of high sample volume. • Partner with QA to translate established quality policies and procedures into AD laboratory-specific SOPs, work instructions, and forms; serve as the primary author of lab-level controlled documents with QA review and approval. • Support implementation of laboratory quality processes — including change control, deviation management, OOS/OOT investigations, and CAPA — in alignment with QA-approved frameworks and applicable regulatory expectations for Phase I/II programs. • Implement QA-defined data integrity requirements within the AD laboratory, ensuring all staff adhere to ALCOA+ principles across paper-based and electronic records, including systems such as Benchling and instrument data acquisition software. • Maintain method qualification records and lifecycle tracking documentation, including qualification status, method changes, and requali