QA Operations Manager

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 are looking for a QA Operations Manager to serve as a trusted Quality partner on the cleanroom floor, providing real-time GMP oversight for our Drug Substance manufacturing operations. In this role, you will lead the development and implementation of quality systems and procedures, drive end-to-end management of quality events including deviations, CAPAs, and change controls, and play a key role in supporting clinical batch disposition. You will partner closely with cross-functional teams across Manufacturing, Supply Chain, Quality Control and Facilities & Engineering to ensure inspection readiness and regulatory compliance as we advance our antibody therapy pipeline. This is a unique opportunity to help shape quality operations at a pivotal stage of AbCellera's growth.

How you might spend your days

• Developing and implementing quality systems and oversight programs for Drug Substance (DS) GMP manufacturing, including product changeovers, batch record review, and shop floor surveillance
• Partnering with CMC teams as the embedded QA representative, contributing quality expertise and guidance to ensure regulatory and quality requirements are seamlessly integrated across CMC projects
• Completing review and approval of GMP documentation - such as batch records, SOPs, logbooks, risk assessments - ensuring full GMP and regulatory alignment and in support of clinical batch disposition
• Maintaining inspection readiness of the facility and identifying and escalating risks to members of the site leadership team 
• Supporting inspections and audits of the clinical manufacturing facility
• Participating in end-to-end quality event management, including deviations, investigations, CAPAs, and change controls, collaborating cross-functionally to drive root cause analysis and on-time record closure
• Contributing to manufacturing risk assessments, from identification and evaluation through to mitigation, documentation, and reporting
• Managing material qualification reviews to support procurement and GMP compliant use of raw materials and components
• Acting as a key quality partner across Manufacturing, QC, Supply Chain, F&E, and project management teams, ensuring seamless quality oversight of DS programs
• Staying ahead of evolving Quality and Regulatory requirements, proactively assessing their impact on AbCellera and driving timely mitigation strategies to maintain compliance
• Supporting broader Quality Assurance activities, as required by program deliverables, such as QA for QC, QA for materials management, and opportunities identified by the Quality team

We'd love to hear from you if

• You hold a Bachelor's or Master's degree in a relevant scientific discipline and bring 8+ years of GxP industry experience, with at least 5 years in a quality management or leadership role within pharmaceuticals, biotechnology, or a comparable regulated environment
• You have a strong command of current pharmaceutical regulations and guidances including FDA, Health Canada, EU, and ICH, and understand how they apply in practice
• You bring hands-on experience with biological Drug Substance and aseptic manufacturing processes, including associated testing requirements
• You're comfortable navigating systems such as ERP (SAP), eQMS, and LIMS, and can hit the ground running in a tech-enabled manufacturing environment
• You communicate with clarity and confidence, equally effective presenting to both technical and non-technical stakeholders
• You're a self-starter who takes ownership, drives results, and thrives with autonomy in a fast-moving, mission-driven environment

What we offer

AbCellera’s hiring range for this role is CAD $105,000 - $120,000 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.

About 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.

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.