QA Specialist - Supplier Quality

The role

This person will provide quality oversight of suppliers that support development and manufacturing activities. They will manage the full supplier lifecycle for materials, equipment, and services used in monoclonal antibody programs.

What you will do

• Selecting, qualifying, and managing a portfolio of suppliers
• Partnering with Procurement, Operations, QC, Supply Chain, and Process Development
• Negotiating and maintaining Quality Agreements
• Managing supplier quality events including deviations, change management, and complaints
• Performing quality risk assessments and defining mitigation plans
• Monitoring and reporting quality performance metrics
• Keeping suppliers ready for regulatory inspections and audits
• Participating in Health Authority and partner inspections
• Staying current on applicable quality and regulatory requirements

Required qualifications

• Bachelor's degree in a relevant scientific discipline with 5+ years of progressive QA experience in a regulated biopharmaceutical, medical device, or life sciences environment
• Master's degree with 3+ years of progressive QA experience in a regulated biopharmaceutical, medical device, or life sciences environment
• Expertise in supplier quality management, including supplier qualification, oversight, and performance monitoring
• 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
• Proven experience managing supplier records and data, quality events, and audit reports in electronic Quality Management Systems and Enterprise Resource Planning system (e.g., Veeva, SAP)
• Exceptional attention to detail
• Firm commitment to data integrity
• Ability to communicate well and collaborate effectively across multidisciplinary teams

Benefits

• Equity
• Annual bonus dependent on team and company performance
• 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• Annual vacation
• Professional development opportunities
• Comprehensive health benefits
• Scientific and technical mentorship

Before you apply

• Submit application through website and refer to Job ID 23411 in cover letter
• Only those selected for an interview will be contacted

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.