Compliance Manager - Montreal - AY Talent

    AY Talent
    AY Talent Montreal

    4 days ago

    Full time
    Description

    Job Summary


    The Compliance Manager is responsible for leading and overseeing compliance initiatives while ensuring adherence of all regulatory requirements in accordance with local and federal laws. This role will focus on planning, executing, and delivering initiatives that ensure regulatory compliance with applicable global standards (FDA, Health Canada, TGA and EMA). This role will also focus on leading the vendor programs. The ideal candidate will bring strong regulatory knowledge, risk assessment capabilities, and cross‑functional collaboration skills to ensure all vendors meet quality, compliance and performance standards.

    Responsibilities & Duties

    • Plan, manage and execute compliance driven initiatives across multiple global jurisdictions
    • Communicate potential risks and mitigation strategies to stakeholders
    • Develop detailed project plans, timelines and resource allocation strategies while ensuring compliance objectives are met
    • Act as a liaison between Quality, Regulatory, Operations, IT and Product Management to ensure seamless execution of cross functional initiatives
    • Lead project meetings, provide status updates, and communicate risks and mitigation plans to stakeholders and senior leadership
    • Track project milestones and deliverables
    • Collaborate with cross‑functional teams to integrate compliance requirements into business processes
    • Develop and deliver strategic compliance training programs to ensure cross‑functional awareness and accountability
    • Serve as a key member of the management team, contributing to corporate compliance strategy and global quality initiatives.

    Oversight of Vendor Qualification Program

    • Design, implement and maintain the vendor qualification program in accordance with global compliance requirements (FDA, Health Canada, EMA and TGA)
    • Lead the qualification and approval process for new vendors, including audits, technical assessments, and quality risk evaluations
    • Develop and maintain vendor risk classifications based on criticality and performance
    • Work with cross‑functional teams (QA, Supply Chain, Procurement, Legal) to ensure proper vendor onboarding and contract quality agreements
    • Establish and track vendor performance metrics
    • Maintain up‑to‑date knowledge of relevant global regulatory requirements and industry best practices related to vendor management

    Develop and Implement Regulatory Strategy for Go to Market in Europe

    • Identify country specific requirements
    • Conduct regulatory gap assessments of current procedures, for implementation in European market
    • Compile European specific documentation
    • Integrate local requirements within Global processes, where applicable
    • Conduct compliance risk assessments prior to product or process launches
    • Maintain licenses and registrations, ensuring SOPs follow applicable regulations

    Staff Development

    • Mentor and develop staff within compliance functions
    • Lead and empower members of the team; guide them to perform at their best. Set and manage clear targets and KPIs and monitor progress.
    • Foster a high driven culture within your team by empowering them to bring their best selves to work.

    Qualifications

    • Bachelor's degree in a Science related field.
    • Minimum of five (5) to seven (7) years experience in a managerial role in Quality, Compliance or Regulatory Affairs, with 10 years total experience
    • Experience in a 503B environment
    • Knowledge of FDA, Health Canada, TGA and EMA regulations
    • Knowledge in project management.
    • Knowledge of Microsoft Office suite (Word, Outlook and Excel) required
    • Knowledge of Creatio and MasterControl is an asset
    • Reliable, accountable, detail‑oriented
    • Organized, very good judgment and decision making skills

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