External QA Manager – Biologics & CMO Quality Oversight

Peptide Atlas; Vancouver; On-site; CAD 84,000 - 122,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Health benefits

Professional development

Job summary

AbCellera is seeking an External QA Specialist/Manager to join the Supplier Quality Management team in Vancouver. You will oversee CMOs involved in monoclonal antibody programs, qualify and manage suppliers, and ensure GMP compliance across manufacturing, labeling, packaging, and storage.

You will work with cross-functional groups on CMO selection, qualification, and quality events, including deviations, CAPAs, and batch release.

Qualifications

• Bachelor’s degree in a scientific discipline; 5+ years of QA in biopharma or life sciences for Specialist, 8+ years for Manager.
• Deep understanding of global cGMPs and regulatory requirements (FDA, Health Canada, EMA, MHRA, PIC/S, ICH).
• Experience with electronic Quality Management Systems and supplier quality data.

Responsibilities

• Provide quality oversight of CMOs for drug product manufacturing, labelling, packaging, and storage.
• Qualify CMOs and suppliers; negotiate and maintain Quality Agreements.
• Partner with cross-functional teams on CMO selection, qualification, and management.
• Oversee deviations, change controls, complaints, MBR/eBR review, and batch disposition.
• Act as Person-in-Plant during campaigns to ensure GMP compliance and product quality.
• Lead risk assessments and mitigation plans; escalate critical issues.
• Maintain CMO site readiness for inspections and audits; monitor outcomes.
• Drive supplier audit responses and CAPAs; verify closure.
• Monitor quality performance metrics and drive continuous improvement.
• Support regulatory submissions and onboarding of new team members.

Skills

Quality oversight

GMP knowledge

Vendor management

Regulatory compliance

QA leadership

Education

Bachelor's degree in a scientific discipline

Tools

Veeva

SAP

QMS systems

Job description

AbCellera is seeking an External QA Specialist/Manager to join the Supplier Quality Management team in Vancouver. You will oversee CMOs involved in monoclonal antibody programs, qualify and manage suppliers, and ensure GMP compliance across manufacturing, labeling, packaging, and storage.

You will work with cross-functional groups on CMO selection, qualification, and quality events, including deviations, CAPAs, and batch release.