abcellera · Vancouver
Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We're looking for an experienced Associate Director/Senior Manager, QA Operations to lead Quality oversight for our biological Drug Substance clinical manufacturing facility (Brightfield) in Vancouver. You'll provide real-time Quality support to cGMP manufacturing, warehousing, and distribution operations, ensuring activities meet regulatory expectations and industry best practices — all while driving continuous improvement and building a strong culture of quality across the site. If you are someone with deep technical expertise in Quality and hands-on GMP leadership experience, who can partner effectively across Manufacturing, Supply Chain, and Regulatory teams to keep operations running smoothly and compliantly, we’d love to hear from you. H ow you might spend your days Owning Quality oversight across GMP manufacturing, warehousing, and distribution, ensuring compliant, uninterrupted operations from clinical stage through future commercial supply Driving batch record review and material disposition, enabling timely release of GMP materials to keep clinical programs moving without delay Leading root cause investigations, CAPAs, and change controls, using structured problem-solving tools to eliminate recurring issues and strengthen GMP operations Providing Quality partnership for tech transfers and new product introductions, including review of technical documents supporting regulatory agency submissions Overseeing material qualification and phase-appropriate release of raw materials and components Championing continuous improvement initiatives that elevate quality performance, compliance, and operational excellence site-wide Shaping Quality policies and procedures, playing a key role in internal and exte…
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