Manager, Quality Assurance
Core
Manage and develop a team of Sr. QA Specialists while directly supporting complex client deliverables for drug importation, foreign site approval, and product release to the Canadian market.
Role type
Senior IC Manager, Quality Assurance (Consulting)
Builds
Drug Establishment Licences, foreign site approvals, commercial drug products, clinical trial supplies, and compliant quality documentation for Canadian market clients.
Domain
Pharmaceutical importation and regulatory compliance (Health Canada, GMP)
Deliverable
client delivery
Required skills
Health Canada regulations, GMP compliance, Drug Establishment Licences, risk assessment, CAPA, audit management, team leadership, project execution, client communication
Preferred skills
Vendor audits, consulting experience, natural health products, AI tools
Technologies
Microsoft Word, Excel, enterprise systems
Responsibilities
Lead and assign day-to-day work of Sr. QA Specialists; Maintain importer Drug Establishment Licences and manage foreign site approval processes; Ensure compliance with Health Canada regulations for drug importation; Perform or oversee release of commercial drug products and clinical trial supplies; Maintain and review internal and client quality documentation; Support recall and mock recall activities; Provide expert consultation to clients on quality matters; Lead or host internal, client, third-party, and regulatory audits.
Seniority
Manager, hands-on people leadership
