External QA Specialist/Manager
AbCellera
AbCellera seeks an experienced External QA Specialist/Manager to oversee contract manufacturing organizations producing monoclonal antibodies. The role spans CMO lifecycle management, supplier qualification, quality agreements, audit oversight, and regulatory compliance for clinical and commercial manufacturing operations.
Responsibilities
- Provide quality oversight of CMO packaging, labeling, storage, and drug product operations for clinical and commercial batches
- Qualify CMOs and suppliers; negotiate and maintain Quality Agreements with external partners
- Act as Person-in-Plant during manufacturing campaigns making real-time quality and GMP decisions
- Conduct quality risk assessments, develop mitigation plans, and escalate critical issues to leadership
- Plan and support Health Authority inspections and third-party audits; evaluate CMO audit responses and CAPAs
Requirements
- Bachelor's degree in relevant scientific discipline
- 5+ years QA experience (Specialist) or 8+ years (Manager) in regulated biopharmaceutical/life sciences
- Expertise overseeing external manufacturing of biologically derived products
- Deep knowledge of global cGMPs and regulatory frameworks (FDA, Health Canada, EMA, MHRA, PIC/S, ICH)
- Understanding of biologics, medical devices, combination products, and clinical trial regulations
- Proficiency with electronic Quality Management Systems and enterprise platforms
Vacancy posted 1 day ago
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