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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Systems Specialist / Spécialiste, Systèmes Qualité based in Canada.
This role plays a key part in ensuring the integrity, compliance, and continuous improvement of a regulated quality system within a fast-evolving clinical research environment. You will act as a guardian of quality processes, helping maintain GxP compliance while supporting audits, inspections, and vendor oversight activities. The position combines operational QA execution with cross-functional collaboration across quality, regulatory, and vendor management teams. You will be responsible for driving inspection readiness, strengthening documentation standards, and ensuring effective CAPA management. In addition to core quality system activities, you will contribute to process improvements and training initiatives that enhance overall quality maturity. This is a highly collaborative role where your work directly supports compliance, patient safety, and operational excellence.
Accountabilities:
- Execute and support internal audit activities, including audit planning, execution, reporting, and follow-up on observations and CAPA closure.
- Review deviations, non-conformities, and quality system findings while tracking trends and ensuring effective CAPA management.
- Support inspection readiness and participate in client audits, regulatory inspections, and mock inspections, including completion of RFIs.
- Contribute to the maintenance and continuous improvement of the Quality Management System (QMS), including documentation updates and quality records.
- Collaborate on vendor management activities, including vendor qualification, risk assessments, and oversight of CAPA related to supplier findings.
- Support quality training initiatives by contributing to training materials and delivering sessions on GxP and quality system topics.
- Perform IP release activities in compliance with GMP requirements, as applicable.
Requirements:
- Bachelor’s degree in a relevant discipline or equivalent experience.
- Minimum of 3 years of experience in quality assurance within pharmaceutical, biotech, or clinical research environments.
- Strong understanding of GxP regulations, including ICH guidelines and requirements from Health Canada, FDA, and EU authorities.
- Experience in audit execution, CAPA management, deviation handling, and quality system documentation.
- Knowledge of Good Clinical Practices (GCP) and familiarity with GMP principles (an asset).
- Strong communication skills in both English and French (written and spoken).
- Excellent organizational skills with the ability to manage priorities in a fast-paced environment.
- Proficiency in Microsoft Office tools and familiarity with digital quality systems.
- Ability to collaborate effectively across multidisciplinary teams and support continuous improvement initiatives.
- Experience in vendor oversight, clinical quality, or therapeutic areas such as dermatology or rheumatology is considered an asset.
- Willingness to travel approximately 10–30% of the time.
Benefits:
- Permanent full-time position with flexible work arrangements.
- Comprehensive benefits package including medical, dental, vision, life, and disability coverage.
- Retirement savings plan (RRSP) with employer support.
- Flexible work schedule and generous vacation, personal days, and holiday leave.
- Access to a virtual healthcare clinic and employee wellness resources.
- Ongoing learning and professional development opportunities.
- Collaborative and supportive work environment focused on quality and innovation.
- Employee perks such as public transportation rebates and social engagement activities.
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