Senior Manager/Associate Director, QA Operations

Job description

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 external audit programs, and translating evolving regulations into practical site systems - Maintaining inspection readiness and serving as a key partner during health authority inspections, proactively identifying and escalating risks to site leadership - Leading risk-based evaluation, mitigation, and reporting initiatives to safeguard product quality and regulatory compliance - Building and coaching a high-performing QA Operations team, managing resourcing and quality metrics/KPIs, and partnering closely with Site Operations, MSAT, Product Development, Quality Control, and Warehouse/Logistics teams to ensure seamless quality oversight of Brightfield's Drug Substance manufacturing programs **W****e’d love to hear from you if** - You have 12 years of GxP industry experience, including at least 5 years in a Quality management or leadership role within pharmaceuticals, biotechnology, or a comparable regulated environment, in addition to a Bachelor’s or Master’s degree - You have a strong command of current pharmaceutical regulations and guidances, including FDA, Health Canada, EU, and ICH, and know how to apply them in practice - You are known for building and leading high-performing Quality teams and coaching your direct reports to help build their technical capabilities, while holding the bar high on accountability - You bring hands-on experience with biological Drug Substance and aseptic manufacturing processes, including the testing requirements that go along with them - You navigate systems such as ERP (SAP), eQMS, and LIMS with ease, and can hit the ground running in a tech-enabled manufacturing environment - You communicate with clarity and confidence, equally effective with technical experts and non-technical stakeholders alike - You're a self-starter who takes ownership, drives results, and thrives on autonomy in a fast-moving, mission-driven environment **W****hat we offer** AbCellera’s hiring range for this role is CAD $124,000 - $155,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials. **A****bout AbCellera** ***Creating medicines is the most important work we can do.*** We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. **To apply** Please submit your application through our website and refer to **Job ID 23366** in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.