QualitySystemsSpecialist/Spécialiste,SystèmesQualité

## 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 approxi