Senior Manager/Associate Director, QA Operations

Vancouver. Posted 2 months ago

The role

You will lead Quality oversight for the biological Drug Substance clinical manufacturing facility in Vancouver. You will provide real-time Quality support to cGMP manufacturing, warehousing, and distribution operations.

What you will do

Own Quality oversight across GMP manufacturing, warehousing, and distribution
Drive batch record review and material disposition
Lead root cause investigations, CAPAs, and change controls
Provide Quality partnership for tech transfers and new product introductions
Oversee material qualification and phase-appropriate release of raw materials and components
Champion continuous improvement initiatives
Shape Quality policies and procedures
Maintain inspection readiness and serve as a partner during health authority inspections
Lead risk-based evaluation, mitigation, and reporting initiatives
Build and coach a high-performing QA Operations team

Required qualifications

12 years of GxP industry experience
At least 5 years in a Quality management or leadership role within pharmaceuticals, biotechnology, or a comparable regulated environment
Bachelor’s or Master’s degree
Strong command of current pharmaceutical regulations and guidances, including FDA, Health Canada, EU, and ICH
Hands-on experience with biological Drug Substance and aseptic manufacturing processes
Experience with ERP (SAP), eQMS, and LIMS

Benefits

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Before you apply

Please submit your application through our website and refer to Job ID 23366 in your cover letter
We are only able to contact those who are selected for an interview

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.