07 Nov
|
Lifelancer
|
Winnipeg
07 Nov
Lifelancer
Winnipeg
Associate Director Quality ManagementJob Location: Kirkland, Quebec, CanadaJob Location Type: RemoteJob Contract Type: Full-timeJob Seniority Level: GeneralGeneral Description: The Regional Clinical Compliance Lead is responsible for leading, developing, and managing a team of Clinical Compliance professionals supporting country- and site-level oversight. This role combines people leadership with operational and strategic accountability to ensure consistent, high-quality execution of risk-based compliance activities. This role plays a critical role in building team capability, driving performance, and ensuring alignment with global compliance strategies while fostering a culture of quality, accountability, and continuous improvement.Serve as the primary point of contact for the RCC country compliance managers team regarding:Oversee preparation, execution, and follow-up activities for inspectionsProvide leadership support during high-impact audits and inspections.Ensure consistent and high-quality execution of risk-based compliance activities across countries and studies.Monitor key performance indicators (KPIs), quality metrics, and compliance trends across the team- Identify systemic risks, recurring issues, and areas for improvement.Ensure timely escalation to Head RCC EMEA and effective resolution of critical compliance issues.Drive accountability for CAPA quality and effectiveness.Provide oversight and quality review of:Remote Compliance ActivitiesRisk identification and mitigation strategiesSite-level compliance assessmentsDrive standardization and harmonization of processes across the team.Resource & Capacity Management Manage and oversee the budget, resource allocation and workload balancing across the team based on study portfolio and risk profile.Ensure appropriate resourcing for high-risk studies, sites,
and compliance activities.Partner with senior leadership on workforce planning and capability needs.Ensure alignment between local execution and global expectations by partnering with:RCC Inspection and Audit LeadRCC Process Excellence and Risk SurveillanceGlobal Clinical ComplianceClinical Operations leadershipQuality Assurance teamsRepresent the function in governance forums and cross-functional discussions.Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelinesAnalytical and problem-solving skillsHigh attention to detail and quality orientationExcellent communication and stakeholder management skillsCommunication & Interpersonal Skills: Excellent English written and verbal communication and interpersonal skillsExcellent organizational skills and ability to prioritize and multi-taskAbility to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environmentSupervisory Responsibilities: Set transparent performance expectations and conduct regular performance reviews (goal setting, mid-year, year-end).Foster a culture of quality, accountability, continuous improvement, and psychological safety.Drive talent management, including succession planning and retention of key talent.Bachelor's degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 8 years of progressive experience in clinical operations roles plus minimum 6 years' experience in a GCP compliance or equivalent role (i.E. quality) including people management experience (minimum 4 years).Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality #
📌 Associate Director Quality Management (Winnipeg)
🏢 Lifelancer
📍 Winnipeg