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Added 13 mins ago
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BioSpace

Associate Manager - Quality Assurance

Mississauga, ON, Canada

Job type: Full-time
Apply by: Oct 19, 2026
Experience: Minimum 5 years of Quality Assurance experience in pharmaceutical, biotechnology, or biologics.
Posting language: English
Posted: Sep 19, 2026

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Original job description

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.

When & Where

Toronto, Canada (hybrid)

Discover Your 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.
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.
You apply sound, risk-based judgment to resolve complex quality and compliance issues.

This Role Requires

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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

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More about this job

Responsibilities

Provide GMP quality oversight and act as Deputy Responsible Person for the batch compilation, review, and release of biologic products for the Canadian market. Oversee importation and distribution activities while managing quality documentation and supporting Health Canada inspections.

Requirements

Requires a Bachelor's degree in Life Sciences and at least 5 years of Quality Assurance experience in pharmaceutical or biotechnology environments. Must have strong knowledge of Health Canada GMP/GDP requirements and experience with quality systems management.

Skills

GMP Quality Oversight
Batch Disposition
Quality Systems Management
Health Canada Compliance
GDP Requirements
Change Control
CAPA
Deviation Management
3PL Oversight
Audit Support
Risk-Based Judgment
Biologics Importation

Benefits

Annual Bonuses
Incentive Plans
Equity Awards
Pension
Retirement Benefits
401(k) Company Match
Health And Wellness Programs
Fitness Centers
Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Paid Time Off
Family Support Benefits

Visa sponsorship

Not detected in the job text

Keywords

GMP
GDP
Quality Assurance
Biologics
Health Canada
Batch Release
CAPA
Change Control
Deviations
APQR
3PL
Quality Systems
Pharmaceuticals
Biotechnology
Regulatory Compliance
Audits
Importation
Distribution

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