Associate Manager - Quality Assurance
Core
Provide GMP quality oversight and act as Deputy Responsible Person for the importation, distribution, and release of biologic products for the Canadian market.
Role type
Associate Manager, Quality Assurance (GMP)
Builds
Commercial and clinical biologic product batches for the Canadian market
Domain
Pharmaceutical/Biologics Quality Assurance (GMP/GDP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP quality oversight, batch record review, batch release, deviations management, change controls, CAPAs, quality systems management, Health Canada GMP/GDP compliance, third-party logistics (3PL) oversight, regulatory inspection support
Preferred skills
Biologics importation/distribution oversight in Canada, medical device importation experience, global quality organization experience
Technologies
GMP, GDP, Health Canada regulatory frameworks
Responsibilities
Act as Deputy Responsible Person for batch compilation, review, disposition, and release; Provide quality oversight for timely batch disposition; Create, revise, and approve quality documentation (Change Controls, Deviations, CAPAs, Complaints, SOPs, APQRs); Monitor quality system metrics and act as escalation point for complex compliance issues; Oversee Canadian importation and distribution activities including 3PL providers; Serve as quality SME supporting Health Canada inspections, audits, self-inspections, and recalls; Collaborate with local and global Quality teams to drive continuous improvement
Seniority
Manager, hands-on IC
