Regeneron
Associate Manager - Quality Assurance
Toronto
Sponsorship not specifiedDetected 13 days ago
LogisticsGMPMedical DevicesProblem Solving
About the role
- 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.
- Monitor quality system metrics and act as escalation point for complex compliance issues.
Responsibilities
- Collaborate with local and global Quality teams and drive continuous improvement of quality standards.
- At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
Requirements
- Canadian Bachelor's degree in a Life Sciences field (Biology, Chemistry, Pharmacy, or equivalent) required.
- Experience with batch record review, batch release, deviations, change controls, CAPAs, and quality systems management.
Compensation
- Where necessary, we disclose salary ranges for roles in all countries in which we operate.
Benefits
- 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.
- Strong understanding of Health Canada GMP and GDP requirements, with experience supporting regulatory inspections and audits.
- Experience with medical device importation in Canada or working in a global quality organisation, an asset.
- Serve as quality subject matter expert (SME) supporting Health Canada inspections, audits, self-inspections, and recalls.
Company info
- 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.
Visa & Work Authorization
- ignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status
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This listing is sourced directly from Regeneron's careers page and normalized into a canonical job model.