Lab Compliance Manager

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 requalification needs, ensuring records are complete and inspection-ready.
• Ensure equipment qualification activities (IQ, OQ, PQ) for AD laboratory instruments are in accordance with QA-approved protocols and maintain calibration and preventive maintenance schedules to ensure equipment remains in a qualified state. Additionally, partner with Facilities & Engineering to oversee the AD equipment as a whole.
• Ensure equipment logbooks and qualification records are maintained in a manner consistent with GDP requirements and inspection readiness expectations.
• Partner with the Analytical Science and Technology (ASAT) group to ensure robust oversight is in place for the receipt, qualification, storage, traceability, and controlled disposal of reference standards and critical reagents used in AD laboratory testing.
• Coordinate and deliver role-based laboratory training in alignment with QA-established training requirements, maintaining training records and qualification documentation for all AD laboratory personnel.
• Ensure AD laboratory documentation, records, and daily practices are maintained in a state of inspection readiness; support QA during internal audits and regulatory inspections by serving as the lab-level point of contact for compliance-related questions.

Requirements: 

• Bachelor's degree in a life sciences discipline (Chemistry, Biochemistry, Biology, or related field), or equivalent combination of education and relevant work experience.
• 8+ years of experience in a compliance, quality, analytical, or laboratory role within the biopharmaceutical, vaccine, or related life sciences industry.
• Working knowledge of GMP and/or GLP principles and their practical application in a laboratory setting, including familiarity with the distinction between GMP policy and lab-level operational procedures.
• Experience authoring or contributing to controlled documents such as SOPs, work instructions, qualification protocols, or investigation reports in a regulated environment.
• Familiarity with data integrity principles (ALCOA+) and Good Documentation Practices (GDP), with demonstrated ability to apply these in day-to-day laboratory operations.
• Experience executing or supporting equipment qualification activities in a regulated analytical or QC laboratory environment.
• Strong interpersonal and collaboration skills, with the ability to work effectively with QA, Analytical Development scientists, and cross-functional teams.
• Effective written and verbal communication skills, with demonstrated ability to translate compliance requirements into clear, practical laboratory procedures.
• Prior experience in a people management or mentorship capacity, or demonstrated readiness to take on direct management responsibilities.

Preferred: 

• Experience at a clinical-stage biopharmaceutical or vaccine company, ideally in a role interfacing with both QA and analytical laboratory functions.
• Familiarity with FDA expectations for Phase I/II QC or analytical laboratory operations supporting early clinical biologics or vaccine programs.
• Experience with electronic laboratory or quality systems such as Benchling, LIMS, or comparable platforms.
• Exposure to 21 CFR Part 11 and electronic records/electronic signatures (ERES) compliance in a laboratory context.
• Prior experience supporting internal audits or regulatory inspections.
• Familiarity with ICH guidelines relevant to analytical methods and early clinical development (Q2, Q6, Q8, Q10).