Senior Manager/Associate Director, QA Operations
AbCellera · Vancouver
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Role summary
AbCellera seeks an Associate Director/Senior Manager, QA Operations to lead Quality oversight at its Brightfield biologics manufacturing facility in Vancouver. The role involves managing GMP compliance, batch reviews, investigations, and process improvements while building and coaching a QA team. Requires 12+ years GxP experience, including 5+ years in Quality leadership, plus deep knowledge of FDA, Health Canada, EU, and ICH regulations.
What they're looking for
- 12 years GxP industry experience including 5+ years in Quality management leadership role
- Bachelor's or Master's degree in relevant field
- Deep knowledge of FDA, Health Canada, EU, and ICH pharmaceutical regulations
- Hands-on experience with biological Drug Substance and aseptic manufacturing processes
- Proven ability to build and lead high-performing Quality teams
- Proficiency with ERP systems, eQMS, and LIMS platforms
- Strong written and verbal communication skills across technical and non-technical audiences
What you'll be doing
- Oversee Quality compliance for GMP manufacturing, warehousing, and distribution operations at Brightfield facility
- Lead batch record reviews and material disposition decisions to enable timely clinical material release
- Direct root cause investigations, CAPAs, and change controls using structured problem-solving approaches
- Support technology transfers and new product introductions with technical document review and regulatory guidance
- Manage material qualification and phase-appropriate release of raw materials and components
Privacy & handoff
This role links to AbCellera's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.