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About the Role
As an Associate Manager, Quality Assurance at Regeneron, you will provide GMP quality oversight and act as Deputy Responsible Person for the importation and distribution of biologic products for the Canadian market. You will collaborate with internal and external stakeholders, including Health Canada, to ensure compliance and drive continuous improvement.
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.
Requirements
- 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.
- Excellent written, verbal, organisational, and problem-solving skills.
- 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.
Skills
- Quality Assurance
- GMP
- GDP
- Batch Record Review
- Batch Release
- Deviations
- Change Controls
- CAPAs
- Quality Systems Management
- Health Canada Regulatory Inspections
- Audits
- Problem-Solving
Location
- Toronto, Canada
Work Type
- Hybrid
Experience Level
- Associate Manager
- 5 years
Education Level
- Canadian Bachelor's degree in a Life Sciences field (Biology, Chemistry, Pharmacy, or equivalent)
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- Regeneron offers a competitive and comprehensive total rewards package.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, 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, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.