Associate Manager - Quality Assurance

Regeneron Pharmaceuticals•Toronto, ON

3d•Hybrid

About The Position

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager, Quality Assurance to join our Quality organisation, supporting the importation and distribution of biologic products for the Canadian market in a hybrid work mode. In this role, you will provide GMP quality oversight and act as Deputy Responsible Person while collaborating with local and global Quality teams, third-party providers, and Health Canada inspectors. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Canadian Bachelor's degree in a Life Sciences field (Biology, Chemistry, Pharmacy, or equivalent) required.
Minimum 5 years of Quality Assurance experience in pharmaceutical, biotechnology, or biologics.
Demonstrated experience within GMP-regulated environments.
Experience with batch record review, batch release, deviations, change controls, CAPAs, and quality systems management.
Strong understanding of Health Canada GMP and GDP requirements, with experience supporting regulatory inspections and audits.
Ability to work independently while collaborating across cross-functional and global teams, with excellent written, verbal, organisational, and problem-solving skills.

Nice To Haves

Experience overseeing biologics importation and distribution in Canada, or oversight of third-party manufacturers and 3PL providers, preferred.
Experience with medical device importation in Canada or working in a global quality organisation, an asset.

Responsibilities

Act as Deputy Responsible Person for batch compilation, review, disposition, and release of 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 act as escalation point for complex compliance issues.
Oversee Canadian importation and distribution activities, including third-party logistics (3PL) providers.
Serve as quality subject matter expert (SME) supporting Health Canada inspections, audits, self-inspections, and recalls.
Collaborate with local and global Quality teams and drive continuous improvement of quality standards.
Apply sound, risk-based judgment to resolve complex quality and compliance issues.