External QA Manager – Biologics CMO Oversight

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

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.