Bilingual (En/Fr) Validation Supervisor

Validation 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