QA Specialist - Supplier Quality

We're looking for an experienced QA Specialist to join our Supplier Quality Management team and help ensure the quality and compliance of the materials, equipment, and services behind our monoclonal antibody programs. In this role, you'll provide quality oversight of the suppliers that support our development and manufacturing activities. You'll be involved across the full supplier lifecycle, from selection and qualification through ongoing management and decommissioning, so that what comes into our process meets the standards our programs depend on.

Responsibilities

Selecting, qualifying, and managing a portfolio of suppliers that provide raw materials, components, reagents, and media, as well as services such as maintenance, calibration, and qualification; Partnering with Procurement, Operations, QC, Supply Chain, and Process Development on supplier selection, qualification, and ongoing management; Negotiating and maintaining Quality Agreements between the company and its suppliers; Managing supplier quality events, including deviations, change management, and complaints; Performing quality risk assessments, defining mitigation plans, and following through on their implementation; Monitoring and reporting quality performance metrics, and implementing continuous improvement initiatives; Keeping suppliers ready for regulatory inspections and for internal, partner, and third-party audits; Participating in Health Authority and partner inspections at sites and ensuring associated action plans are implemented; Staying current on applicable quality and regulatory requirements and evolving industry trends

Requirements

Bachelor's degree in a relevant scientific discipline with 5+ years of progressive QA experience (or a Master's with 3+ years) 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 systems (e.g., Veeva, SAP); Exceptional attention to detail and a 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; Community and connections through work, clubs, and socials