Lab Compliance Manager (Biopharma)

Location: San Carlos, CA; onsite at least 5 days per week

Salary: $153,000–$178,000 per year in the San Francisco Bay Area; ranges may vary for non-California locations.

Company

hirify.global is a biopharmaceutical company developing vaccine programs supported by analytical development and laboratory testing capabilities.

What you will do

• Manage the Sample Management Specialist and oversee sample receipt, logging, storage, distribution, disposition, chain of custody, and GDP compliance.
• Partner with QA to create laboratory SOPs, work instructions, forms, and other controlled documents.
• Implement change control, deviation management, OOS/OOT investigations, CAPA, and data integrity processes for analytical development laboratories.
• Maintain method qualification records, equipment qualification documentation, calibration schedules, preventive maintenance, and inspection-ready logbooks.
• Oversee reference standards and critical reagents in partnership with Analytical Science and Technology.
• Coordinate laboratory training and support internal audits and regulatory inspections as the lab compliance point of contact.

Requirements

• Bachelor’s degree in chemistry, biochemistry, biology, or a related life sciences discipline, or equivalent education and experience.
• 8+ years of experience in compliance, quality, analytical, or laboratory roles within biopharmaceutical, vaccine, or related life sciences organizations.
• Working knowledge of GMP and/or GLP principles and their application in laboratory operations.
• Experience authoring controlled documents and supporting equipment qualification in a regulated analytical or QC laboratory.
• Practical knowledge of ALCOA+ data integrity principles and Good Documentation Practices.
• Strong collaboration, communication, people-management, and laboratory procedure development skills.

Nice to have

• Experience in a clinical-stage biopharmaceutical or vaccine company.
• Familiarity with FDA expectations for Phase I/II QC or analytical laboratory operations.
• Experience with Benchling, LIMS, or comparable electronic laboratory and quality systems.
• Knowledge of 21 CFR Part 11, electronic records and signatures, and relevant ICH guidelines.
• Experience supporting internal audits or regulatory inspections.

Culture & Benefits

• Onsite work in San Carlos, California.
• Comprehensive benefits package.
• Equity component included in the compensation package.
• Collaboration across Quality Assurance, Analytical Development, Analytical Science and Technology, and Facilities & Engineering.