Biologics QA Lead — Canada Compliance & Release

Regeneron; Mississauga; Hybrid; CAD 90,000 - 130,000; Full time

Job summary

Regeneron in Toronto, Canada, is hiring an Associate Manager, Quality Assurance to support the importation and distribution of biologics in a hybrid work model. You will provide GMP quality oversight and act as Deputy Responsible Person, collaborating with local and global Quality teams, 3PL providers, and Health Canada inspectors.

The role requires a Canadian Life Sciences degree and 5+ years in QA within GMP environments, with strong documentation and regulatory inspection experience.

Qualifications

• Bachelor's degree in Life Sciences (Biology, Chemistry, Pharmacy) required.
• Minimum 5 years of Quality Assurance experience in pharmaceutical/biotech/biologics.
• Experience in GMP-regulated environments.
• Experience with batch record review, deviations, CAPAs, change controls, and quality systems management.
• Strong understanding of Health Canada GMP and GDP; experience with regulatory inspections and audits.
• Ability to work independently and with cross-functional/global teams; strong written/verbal/organizational/problem-solving skills.
• Experience overseeing biologics importation/distribution in Canada or oversight of 3PL providers is preferred.
• Experience with medical device importation in Canada or global quality organization is an asset.

Responsibilities

• Act as Deputy Responsible Person for batch compilation, review, disposition, and release for Canadian-market products.
• Provide quality oversight for timely batch disposition of commercial and clinical biologic products.
• Create, revise, and approve quality documentation including Change Controls, Deviations, CAPAs, Complaints, SOPs, and APQRs.
• Monitor quality system metrics and escalate complex compliance issues.
• Oversee Canadian importation and distribution activities, including third-party logistics providers.
• Serve as quality SME supporting Health Canada inspections, audits, self-inspections, and recalls.
• Collaborate with local and global Quality teams to drive continuous quality improvement.
• Apply sound, risk-based judgment to resolve complex quality and compliance issues.

Skills

Quality Assurance

GMP Compliance

Regulatory Inspections

Cross-functional Collaboration

Problem Solving

Health Canada Knowledge

Education

Bachelor's degree in Life Sciences

Job description

Regeneron in Toronto, Canada, is hiring an Associate Manager, Quality Assurance to support the importation and distribution of biologics in a hybrid work model. You will provide GMP quality oversight and act as Deputy Responsible Person, collaborating with local and global Quality teams, 3PL providers, and Health Canada inspectors.

The role requires a Canadian Life Sciences degree and 5+ years in QA within GMP environments, with strong documentation and regulatory inspection experience.