Reference no. R2871503

Position title: Quality Assurance Specialist

Department: QA DS B89/90

Location: Toronto, ON

About the job

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

Our Team/ Overview:

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.

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:

- Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
- Ensuring compliance with Positive Manufacturing Practices (GMP) and other relevant regulations




- Conducting regular audits of production processes to identify and address potential quality issues
- Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
- Managing and resolving quality-related issues in a timely and effective manner
- Monitoring and analyzing quality performance metrics, implementing corrective actions as needed
- Leading root cause analysis investigations for quality incidents and implementing preventive measures
- Participating in internal and external audits and regulatory inspections providing support and documentation
- Developing and implementing risk management strategies to mitigate potential quality issues
- Fostering a culture of quality and continuous improvement across the organization

Section 3: Key Involvement in Decision-Making Process

Key Roles (D,A,I)

- Request corrections when GMP rules are not respected (D)
- Prioritize quality and compliance objectives (A)
- Proactively implement remediation action from findings from internal and external audits related to quality issues (D)
- Request quality improvement initiatives and strategies (D)
- Identify discrepancies and corrective/preventive actions that need to be taken (D)




- Escalate to upper management any failure in GMP execution on shopfloor (I)
- Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)
- Advise on how to present a topic and answer specific questions (A)
- Advise on risk management strategies and plans (A)
- Advise on initiatives to promote a quality-focused culture (A)

Section 4: Local specificities

Additional Accountabilities

- Provide QA support to any required APU or PCU on site as designated by the QA Ops Manager & PCU Lead
- Any other duties that may arise as required

About you

Education / Experience Requirements:

- Bachelor's degree or higher preferably in Pharmacy, Chemistry, Biochemistry, Life Sciences, Chemical Engineering, or a related scientific field
- Minimum 2 years of experience in pharmaceutical quality assurance or operations (depending on level)

Technical Skills:

- 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 / Preventive Action
- Regulatory Requirements
- QA Standards
- Documentation Review
- Manufacturing Processes
- Product Quality Assurance
- Risk Management
- Cross-Team Communication and Collaborati

📌 Quality Assurance Specialist (Toronto)
🏢 Sanofi
📍 Toronto