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About the Role

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 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.

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

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.
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

GMP quality oversight
Deputy Responsible Person
Quality documentation
Change Controls
Deviations
CAPAs
Complaints
SOPs
APQRs
Quality system metrics
Compliance issues
Canadian importation and distribution
Third-party logistics (3PL) providers
Health Canada inspections
Audits
Self-inspections
Recalls
Continuous improvement
Risk-based judgment
Problem-solving skills
Written communication
Verbal communication
Organisational skills

Location

Toronto, Canada

Work Type

Hybrid

Experience Level

Associate Manager
Minimum 5 years of Quality Assurance experience

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.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.
Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.
Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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.