Lab Compliance Manager
Core
Primary compliance partner for Analytical Development (AD) laboratories, ensuring GMP/GLP compliance, operationalizing quality policies, and guiding the transition to a Phase I/II clinical release QC lab.
Role type
Lab Compliance Manager (hands-on IC with management responsibilities)
Builds
GMP-compliant analytical laboratory operations for early clinical vaccine/biologic programs
Domain
Biopharmaceuticals / Vaccines / Analytical Development
Required skills
GMP/GLP principles, SOP authoring, deviation management, data integrity (ALCOA+), equipment qualification (IQ/OQ/PQ), change control, CAPA, regulatory inspection readiness, people management
Preferred skills
Clinical-stage biopharma experience, FDA Phase I/II QC expectations, electronic lab systems (Benchling/LIMS), 21 CFR Part 11, ICH guidelines (Q2, Q6, Q8, Q10)
Technologies
Benchling, LIMS, instrument data acquisition software
Responsibilities
Manage Sample Management Specialist; translate QA policies into lab SOPs; implement change control, deviation management, and CAPA; ensure data integrity and equipment qualification; support internal audits and regulatory inspections; coordinate role-based training
Seniority
Senior, hands-on IC with direct reporting line