Quality Assurance Specialist Days

BioTalent Canada; Toronto; On-site; CAD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Career growth opportunities

Rewards program

Global collaboration

Job summary

Sanofi is seeking a Quality Assurance professional in Toronto to uphold GMP standards and ensure product excellence. You will audit production, collaborate with cross-functional teams, and drive continuous improvement across the organization.

You will review quality systems, manage investigations, and support regulatory inspections while maintaining meticulous documentation and a strong shopfloor presence. 2–5+ years in pharma QA is preferred.

Qualifications

• 2–5+ years in pharmaceutical quality assurance or operations.
• Experience with DP/Drug Substance quality operations.
• Knowledge of cGMP and GxP regulations in pharma.

Responsibilities

• Ensure activities comply with GMP and regulatory requirements.
• Audit production processes to identify quality issues.
• Collaborate with production to maintain quality across the lifecycle.
• Manage and resolve quality-related issues promptly.
• Monitor quality metrics and implement corrective actions.
• Lead root cause investigations and preventive actions.
• Participate in audits and inspections, providing documentation.
• Develop risk management strategies to mitigate issues.
• Foster culture of quality and continuous improvement.
• Provide QA support to designated units on site as required

Skills

Quality Assurance

GMP compliance

Auditing

Root Cause Analysis

Change Control

Documentation review

Regulatory compliance

Cross-team collaboration

Stakeholder management

Education

Bachelor's degree

Job description

The Quality Assurance team serves as a critical guardian of patient safety and product excellence through rigorous GMP record review and batch release activities, while fostering a culture of quality ownership and continuous improvement across operations. Through systematic oversight and shopfloor expertise, we proactively identify and mitigate quality risks, maintain robust quality systems, and ensure full regulatory compliance. Our collaborative partnerships across all functions embed quality principles into every aspect of operations, enabling the timely delivery of high-quality products to patients while upholding the highest standards of operational excellence.

This is a day shift role (8AM – 4PM, Fri to Tue)- subject to change.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

• Ensure all activities are conducted in compliance with applicable regulatory requirements and Good Manufacturing Practices (GMP)
• Conduct regular audits of production processes to identify and address potential quality issues
• Collaborate closely with production teams to maintain quality standards throughout the product lifecycle, with a strong shopfloor presence
• Manage and resolve quality-related issues in a timely and effective manner
• Monitor and analyze quality performance metrics, implementing corrective actions as needed
• Lead root cause analysis investigations for quality incidents and implement preventive measures
• Participate in internal and external audits and regulatory inspections, providing support and documentation
• Develop and implement risk management strategies to mitigate potential quality issues
• Foster a culture of quality and continuous improvement across the organization
• Provide QA support to designated APU or PCU units on site as required

About you

Qualifications & Experience:

Education:

• Bachelor’s degree or higher in Pharmacy, Chemistry, Biochemistry, Life Sciences, Chemical Engineering, Engineering, or a related scientific field

Experience:

• 2–5+ years of experience in pharmaceutical quality assurance or operations
• Demonstrated experience in Drug Substance/Drug Product (DP) quality operations
• Working knowledge of cGMP and GxP regulations in a regulated pharmaceutical environment
• Experience with quality documentation, compliance activities, and regulatory requirements
• Familiarity with change control processes and quality systems
• Background in process improvement and quality investigations
• Quality Assurance and Change Control Processes
• Inspection Readiness
• Root Cause Analysis (RCA) and Preventive Action
• Regulatory Requirements and QA Standards
• Documentation Review
• Manufacturing Processes and Product Quality Assurance
• Cross-Team Communication and Collaboration
• Stakeholder Management

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs.

AI Usage

“Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information toidentify patterns, improve services, or support decision‑making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concernregardingyour personal information. You can also contact Canada’s Privacy Officer via Sanofi’s datasubject request portal,can also be used torequest access or correction of your personal information and file a complaint.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never‑been‑done‑before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.