Hiring: Lab Compliance Manager Company: Vaxcyte Location: San Carlos, CA Job Posted Time: 2026-09-03 10:36:35 Employment Type: Hybrid About the job Experience: •8+ years of experience in a compliance, quality, analytical, or laboratory role within the biopharmaceutical, vaccine, or related life sciences industry. Required Skills: •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. •Actively facilitate and support 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. Qualifications: •Bachelor's degree in a life sciences discipline (Chemistry, Biochemistry, Biology, or related field), or equivalent combination of education and relevant work experience. •Solid functional 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. •Operational familiarity with data integrity principles (ALCOA+) and Good Documentation Practices (GDP), with demonstrated ability to apply these in day-to-day laboratory operations. •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. •Operational familiarity with FDA expectations for Phase I/II QC or analytical laboratory operations supporting early clinical biologics or vaccine programs. •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. •Operational familiarity with ICH guidelines relevant to analytical methods and early clinical development (Q2, Q6, Q8, Q10). Compensation: •$153,000 - $178,000 / year •Competitive benefits and rewards package •The compensation package will be competitive and includes comprehensive benefits and an equity component Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!