Quality Systems Specialist (Bilingual English/French)

About the role

The Quality Systems Specialist ensures the integrity, compliance, and continuous improvement of a regulated quality system within a fast‑evolving clinical research environment. Working closely with quality, regulatory, and vendor management teams, you will act as a guardian of GxP processes, supporting audits, inspections, and training initiatives.

Key responsibilities

• Plan, execute, and report internal audits; follow up on observations and CAPA closure.
• Review deviations, non‑conformities and quality findings, track trends, and manage CAPA actions.
• Support inspection readiness and participate in client audits, regulatory inspections, mock inspections and RFIs.
• Maintain and improve the Quality Management System (QMS) documentation and records.
• Collaborate on vendor qualification, risk assessments, and oversight of supplier‑related CAPA.
• Contribute to quality training materials and deliver sessions on GxP and quality system topics.
• Perform investigational product release activities in compliance with GMP, when required.

Required profile

• Bachelor’s degree in a relevant discipline or equivalent experience.
• Minimum 3 years of quality assurance experience in pharmaceutical, biotech or clinical research.
• Strong knowledge of GxP regulations (ICH, Health Canada, FDA, EU) and Good Clinical Practices.
• Excellent written and spoken communication in English and French.
• Strong organizational skills and ability to manage priorities in a fast‑paced environment.
• Proficiency with Microsoft Office and familiarity with digital quality systems.

Required skills

• Microsoft Office
• Digital quality management systems
• CAPA management
• Audit execution
• Deviation handling