Are you passionate about pharmaceutical quality assurance and compliance? Ethypharm, a global specialty pharmaceutical company, is looking for a dedicated Quality Assurance Specialist to join our team in Montreal.

Reporting to the Director of Drug Safety & Compliance this pivotal role will uphold the highest standards of quality for our pharmaceutical products distributed across North America. You will collaborate with international and local teams, ensuring compliance with both Canadian and U.S. regulations while playing an active role in shaping and maintaining our local Quality System. You will have experience or be keen to learn and broaden your knowledge to undertake additional tasks within Pharmacovigilance and Regulatory Affairs as needed.

Key responsibilities

• Maintain and implement the local Quality System in compliance with Canadian and U.S. regulations and company policies.
• Manage and oversee GxP activities such as change controls, deviations, CAPAs, product complaints, temperature excursions, product returns/destruction, and artwork implementation.
• Act as the quality liaison for service providers, with a focus on third-party logistics partners.
• Review and approve GxP documentation including Master Batch Records and promotional materials.
• Coordinate and perform product release and rejection processes.
• Maintain SOPs, quality/technical agreements, and training files.
• Support inspections, audits, and annual product quality reviews.
• Collaborate with internal departments (Regulatory Affairs, Pharmacovigilance) and international teams.
• Ensure ongoing monitoring of GxP activities, track KPIs, and support continuous improvement initiatives.

Requirements

Essential:

• BSc in a Science discipline.
• Minimum 3 years of experience in pharmaceutical Quality Assurance, Compliance, or related areas.
• Experience in Drug Product release and document review.
• Strong knowledge of Canadian Drug Regulations, GMP, and related guidelines.
• Bilingual in French and English (oral and written).
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Excellent organizational, communication, and decision-making skills.

Desirable

• Experience with U.S. regulatory frameworks (FDA, cGMP).
• Familiarity with ICH standards and European regulations.
• Exposure to Pharmacovigilance guidelines and Risk Management practices.
• Audit and inspection experience.
• Previous trainer or team lead experience.

We recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business.

Please contact us for a full role profile

About Ethypharm Group

Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine.

Our commitment is to improve patients' lives and make a positive impact on society and the environment.

Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations

Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms.

With a global presence in 68 countries, the company markets its products directly in Europe and China, and has strategic partnerships in the EMEA, NA, LATAM and APAC markets.

Ethypharm works closely with the authorities and healthcare professionals to ensure that its medicines are used appropriately and that patients have access to them.

To find out more about Ethypharm, visit and follow us on LinkedIn.