Quality Assurance Specialist Afternoon

R2871753 Quality Assurance Specialist Afternoon (Weekends)

Location:

Toronto, ON Duration:
Fixed term, 12 months afternoon shift (Fri to Tue - 4pm to 12am)

At Sanofi, we chase the miracles of science to improve people's lives.

We are dedicated to making a positive impact on the lives of patients and their families by developing innovative therapies and ensuring the highest standards of quality and safety.

Our team is united by a shared purpose — transforming the practice of medicine by working to turn the impossible into the possible.

Join us and help shape the future of healthcare.

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 role is for an weekend's afternoon shift (Fri to Tue - 4pm to 12am) - subject to change as per business needs.

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.

• 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

• 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
• Risk Management
• Cross-Team Communication and Collaboration
• Stakeholder Management

• Bring the miracles of science to life…