External QA Specialist/Manager

AbCellera Biologics Inc.; Vancouver (WA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Active lifestyle allowance

Health benefits

Professional development

Mentorship

Job summary

AbCellera Biologics Inc. is seeking an External QA Specialist/Manager to provide quality oversight of CMOs involved in monoclonal antibody programs. You will act as the on-site quality authority during campaigns and ensure GMP compliance across labeling, packaging, and storage.

You will qualify suppliers, maintain quality agreements, review batch records, and collaborate with cross-functional teams to drive risk-based decisions and continuous improvement across the supplier network.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 5+ years (Specialist) or 8+ years (Manager) of progressive QA experience in a regulated biopharmaceutical, medical device, or life sciences environment.
• Deep understanding of global cGMPs and regulatory requirements (FDA, Health Canada, EMA, MHRA, PIC/S, ICH).
• Experience with electronic Quality Management Systems and enterprise platforms (e.g., Veeva, SAP) to oversee CMO quality events and batch review.
• Strong attention to detail and commitment to data integrity.
• Excellent collaboration across multidisciplinary teams and external partners.

Responsibilities

• Provide quality oversight of CMOs for drug product manufacturing, labeling, packaging and storage.
• Qualify CMOs and service providers; negotiate and maintain Quality Agreements.
• Collaborate with Procurement, Operations, QC, Supply Chain on CMO selection and oversight.
• Oversee deviations, change controls, complaints, MBR/eBR review, and batch disposition.
• Act as Person-in-Plant during campaigns; ensure GMP compliance and timely decisions.
• Lead quality risk assessments and mitigation plans; escalate critical issues.
• Prepare for inspections; coordinate audits and corrective actions.
• Monitor supplier QA metrics and drive continuous improvement.
• Support regulatory submissions and onboarding of new team members.

Skills

QA experience

cGMP know-how

Regulatory knowledge

Data integrity

Veeva / SAP

Cross-functional teamwork

IMP supply chains

Education

Bachelor's degree in a scientific discipline

Tools

Veeva

SAP

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 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, escalating critical issues, and protecting 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.