Manager, Quality Assurance

Role overview Lead a team of senior quality specialists while remaining hands-on with complex client and compliance work. The role oversees licensing and foreign site approvals, quality documentation, and release activities for products entering the Canadian market, with an emphasis on timely, risk-based decisions and dependable delivery across multiple projects.

Responsibilities - Assign and balance the team’s daily workload, coach and train specialists, and build consistent practices and accountability. - Maintain importer establishment licences and coordinate foreign site approval activities for multiple clients. - Perform or oversee release of commercial medicines and clinical trial supplies for the Canadian market. - Review and maintain quality records, including procedures, product quality reviews, stability reports, validation documents, artwork, and temperature studies. - Ensure deviations, corrective and preventive actions, complaints, change controls, and trend reviews are handled thoroughly and on time. - Advise clients and internal teams on quality risks and practical compliant responses; support audits, inspections, and recall exercises as needed.

Requirements - Experience leading or developing quality specialists while managing complex quality deliverables. - Sound judgment to assess compliance risk, make timely decisions within authority, and escalate issues appropriately. - Ability to manage multiple client projects and deadlines with accuracy, ownership, and follow-through. - Strong client-facing communication skills, including explaining quality positions and answering questions collaboratively. - Ability to build effective relationships with internal partners, clients, foreign sites, and external stakeholders. - Flexibility to adapt to changing priorities and work independently as well as across multidisciplinary teams.

Benefits and work setup Travel may be required up to 20%. The role does not require shift work unless business needs change. Benefits include health coverage and support for family care, professional development, and mentorship.