Regeneron Pharmaceuticals, Inc

Associate Manager - Quality Assurance

Regeneron Pharmaceuticals, Inc$80K — $100K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Canadian Bachelor's degree in Life Sciences required (Biology, Chemistry, Pharmacy, or equivalent)
  • Minimum 5 years of Quality Assurance experience in pharmaceutical, biotechnology, or biologics
  • Experience in GMP-regulated environments
  • Familiarity with batch record review, batch release, deviations, change controls, CAPAs, and quality systems management
  • Strong understanding of Health Canada GMP and GDP requirements
  • Ability to work independently and collaboratively with cross-functional teams
  • Preferred experience with biologics importation and distribution, overseeing 3PL providers

Responsibilities

  • Act as Deputy Responsible Person for batch management and product release
  • Provide quality oversight for biologic products
  • Create, revise, and approve quality documentation
  • Monitor quality system metrics and manage complex compliance issues
  • Oversee importation and distribution activities in Canada
  • Serve as quality SME for inspections, audits, and recalls
  • Drive continuous improvement of quality standards

Benefits

  • Hybrid work model in Toronto, Canada
  • Opportunities for professional development and growth
  • Collaboration with local and global quality teams
  • Engagement in cross-functional projects
  • Contribution to impactful health solutions
Full Job Description

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.

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ

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