Job SummaryThe 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 solid regulatory knowledge, risk assessment capabilities, and cross‐functional collaboration skills to ensure all vendors meet quality, compliance and performance standards.Responsibilities & DutiesPlan, manage and execute compliance driven initiatives across multiple global jurisdictionsCommunicate potential risks and mitigation strategies to stakeholdersDevelop detailed project plans, timelines and resource allocation strategies while ensuring compliance objectives are metAct as a liaison between Quality, Regulatory, Operations, IT and Product Management to ensure seamless execution of cross functional initiativesLead project meetings, provide status updates, and communicate risks and mitigation plans to stakeholders and senior leadershipTrack project milestones and deliverablesCollaborate with cross‐functional teams to integrate compliance requirements into business processesDevelop and deliver strategic compliance training programs to ensure cross‐functional awareness and accountabilityServe as a key member of the management team, contributing to corporate compliance strategy and global quality initiatives.Oversight of Vendor Qualification ProgramDesign, 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 evaluationsDevelop and maintain vendor risk classifications based on criticality and performanceWork with cross‐functional teams (QA, Supply Chain, Procurement, Legal) to ensure proper vendor onboarding and contract quality agreementsEstablish and track vendor performance metricsMaintain up‐to‐date knowledge of relevant global regulatory requirements and industry best practices related to vendor managementDevelop and Implement Regulatory Strategy for Go to Market in EuropeIdentify country specific requirementsConduct regulatory gap assessments of current procedures, for implementation in European marketCompile European specific documentationIntegrate local requirements within Global processes, where applicableConduct compliance risk assessments prior to product or process launchesMaintain licenses and registrations, ensuring SOPs follow applicable regulationsStaff DevelopmentMentor and develop staff within compliance functionsLead 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.QualificationsBachelor'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 experienceExperience in a 503B environmentKnowledge of FDA, Health Canada, TGA and EMA regulationsKnowledge in project management.Knowledge of Microsoft Office suite (Word, Outlook and Excel) requiredKnowledge of Creatio and MasterControl is an assetReliable, accountable, detail‐orientedOrganized, very good judgment and decision making skills

📌 Compliance Manager (Montreal)
🏢 AY Talent
📍 Montreal