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 who 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 External QA Specialist/Manager to join our Supplier Quality Management team and help ensure the quality of the Contract Manufacturing Organizations (CMOs) behind our monoclonal antibody programs. In this role, you'll provide quality oversight of the CMOs involved in manufacturing our monoclonal antibodies, including clinical and commercial batch manufacturing, labelling, packaging, and storage. You'll be involved across the full CMO lifecycle, from selection and qualification through ongoing management and decommissioning. You'll also support risk-based quality oversight of our broader network of suppliers and service providers, helping ensure they are properly qualified, consistently overseen, and compliant over time. If you're a QA professional who enjoys building strong partnerships with external manufacturers and takes pride in keeping quality at the center of every handoff, we'd love to hear from you.
How you might spend your days
- Providing quality oversight of clinical and commercial packaging, labelling, and storage operations at CMOs (drug product, including active and placebo lots), and serving as Labelling/Packaging SME and Quality point of contact for future internal operations
- Qualifying CMOs, service providers, and suppliers, and negotiating and maintaining Quality Agreements with them
- Partnering with Procurement, Operations, QC, Supply Chain, Process Development, Legal, and external partners on CMO selection, qualification, and management, and aligning on quality topics across CMC programs
- Supporting oversight of CMO and supplier quality activities, including deviations, change controls, complaints, master batch record (MBR/eBR) review, and batch disposition/release
- Acting as Person-in-Plant (PIP) during manufacturing campaigns, serving as the on-site quality authority to make real-time, risk-based decisions, escalate critical issues, and protect GMP compliance and product quality
- Performing quality risk assessments, developing mitigation plans, following up on implementation, and escalating critical quality issues for timely resolution at program and leadership level
- Maintaining CMO site readiness for Health Authority inspections and for internal, partner, and third-party audits, participating in GMP audits of CMOs and suppliers, and monitoring inspection and audit outcomes to ensure action plans are implemented
- Evaluating and driving CMO and supplier audit responses and CAPAs, ensuring actions fit the root cause, are effectively implemented, and are verified through to closure
- Monitoring and reporting quality performance metrics, driving continuous improvement initiatives, and staying current on applicable quality and regulatory requirements and trends
- Supporting CMC regulatory submissions and the onboarding and training of new team members on supplier quality expectations
We’d love to hear from you if
- You have a Bachelor's degree in a relevant scientific discipline and 5+ years (Specialist) or 8+ years (Manager) of progressive QA experience in a regulated biopharmaceutical, medical device, or life sciences environment, including expertise in overseeing external manufacturing of biologically derived products
- You have a deep understanding of global cGMPs and regulatory requirements (FDA, Health Canada, EMA, MHRA, PIC/S, ICH) covering biologics, medical devices, combination products, and clinical trials
- You have a strong track record of leveraging electronic Quality Management Systems and enterprise platforms (e.g., Veeva, SAP) to oversee CMO quality events, drive timely batch record review and disposition, and use supplier performance data to inform risk-based decisions
- You bring exceptional attention to detail and a firm commitment to data integrity
- You communicate well and collaborate effectively across multidisciplinary teams and external partners
- You have experience with investigational medicinal product (IMP) supply chains (an asset)
What we offer
AbCellera’s hiring range for the Specialist role is CAD $84,000 - $105,000 annually and for the Manager role is CAD $98,000 - $122,000 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.
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 23412 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.