Website Synergie
Synergie is seeking an experienced Quality Assurance Manager to support our client in overseeing all product distribution quality activities within Canada. This role is critical in ensuring full compliance with cGMP and GDP standards, managing GMP release of commercial products, and maintaining robust Canadian quality systems.
Location: Toronto, ON
Pay Rate: $60–$65/hour
Type: Contract – Full-time
Industry: Biotechnology / Pharmaceuticals
About the Role: Synergie is seeking an experienced Quality Assurance Manager to support our client in overseeing all product distribution quality activities within Canada. This role is critical in ensuring full compliance with cGMP and GDP standards, managing GMP release of commercial products, and maintaining robust Canadian quality systems.
You will collaborate closely with cross-functional internal teams, contract manufacturing organizations, and external laboratories to ensure products meet both the company’s Quality Management System (QMS) and Canadian regulatory requirements.
Key Responsibilities
•Manage GMP release and batch certification of all Canadian commercial products.
•Maintain Canadian quality systems, including SOPs, Quality Agreements, and site master files.
•Support internal audits, self-inspections, and external audits of warehouses and laboratories.
•Prepare for and support Health Canada inspections, including managing corrective actions.
•Oversee product recalls and conduct annual mock recalls.
•Monitor and report quality performance metrics; lead Quality Management Reviews.
•Manage product complaints, risk identification, and CAPA processes.
•Ensure training programs for relevant staff are implemented and maintained.
•Act as a Subject Matter Expert (SME) in global quality projects.
Qualifications
•Bachelor’s degree in Life Sciences, Biotechnology, or related field.
•Minimum 6 years of quality assurance/control experience in a regulated pharmaceutical or biotechnology environment.
•Proven expertise in GMP and GDP, with knowledge of Canadian, US, and global regulatory requirements.
•Strong leadership skills, with the ability to mentor and build cross-functional relationships.
•Lead Auditor experience.
•Proficiency in MS Office applications (Word, Excel, PowerPoint).
•Experience with biologics, cell & gene therapy, and GVP/GCP/GLP is an asset.
What We Offer
•Competitive hourly rate of $60–$65.
•Opportunity to work with a leading global biopharmaceutical company.
•Professional growth in a fast-paced, high-impact role.
To apply for this job email your details to jdinatale@synergie.ca
