IntroductionWe are currently recruiting for a Bilingual (Fr/En) Validation Supervisor for our client. As a Validation Supervisor at a leading pharmaceutical company specializing in sterile products, you will play a crucial role in ensuring that all site processes, equipment, and systems adhere to stringent regulatory standards. You will lead a team of validation specialists to manage validation projects, oversee protocol documentation, and collaborate with cross-functional teams to support new product processes and site modifications. This is a full-time permanent opportunity to work in a hybrid schedule in the Montérégie region.
ResponsibilitiesValidation Program Oversight & Compliance:Oversee validation activities and projects, ensuring compliance with regulatory standards and internal procedures.Maintain and improve the validation program to meet FDA and Health Canada requirements.Support new product processes and collaborate with regulatory teams to ensure compliance.Documentation & Reporting:Prepare and review validation protocols and reports for equipment, cleaning, processes, and computer systems.Maintain the validation documentation system and coordinate reviews of existing equipment validations.Coordination & Execution:Coordinate validation activities with Production, Quality, and Technical Services teams.Lead validation, revalidation, and qualification efforts to support site modifications and upgrades.Team & Performance Management:Lead and develop a team of 3 validation specialists, including recruitment, training, and performance management.Monitor and report on monthly validation KPIs and metrics.Manage consultants and proactively address performance issues to ensure alignment with business goals.Training & Internal Support:Promote and explain validation strategies to internal teams and provide training as needed.Participate in regulatory inspections and manage response processes.Continuous Improvement:Continuously enhance the validation system to meet evolving regulatory requirements.Conduct risk assessments and manage validation-related investigations.Ad hoc duties
RequirementsBachelor’s degree in science5-10 years of experience, including at least 2 years in a sterile pharmaceutical setting and 3 years in personnel managementStrong presentation, and verbal and written communication skills in both English & FrenchProficient in Microsoft Office Suite (Word, Excel)Comprehensive understanding of pharmaceutical regulationsTrack record of meeting business goalsStrong project management and problem-solving skillsAbility to effectively advocate for regulatory positionsProficient in interpreting and applying standardsExcellent organizational abilities deadline management and adaptability to changing priorities
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