• Development and execution of the overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) • Proactively identify critical to quality risks and mitigation strategy to drive excellence in study execution and to minimize risk to regulatory submission/approval. • Proactively identify Key Quality and Risk Indicators (KQIs/KRIs) for assigned Therapeutic Areas and develops mechanisms of KQI/KRI, detection, oversight and trending with Clinical Operations leadership and other stakeholders and functions such as Risk based Quality Management • Proactively escalate risks that may impact Country level Key Quality and Risk Indicators (KQIs/KRIs) and collaborate on mechanisms to provide quality oversight at study/country level• Serve as the quality expert for global/systemic clinical quality issue • Be accountable for leading inspection readiness for assigned programs/portfolio • Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable e.g., TMF health oversight, CRO/Vendor oversight, medical device requirements etc.

• Provide expertise to internal functions in the application, maintenance, and improvement of quality systems and specific procedures/processes used in clinical research• Create, revise, and review departmental Standard Operating Procedures (SOPs)• Provide review of preclinical and clinical trial protocols to ensure GLP/GCP Compliance• Provide review and approval for process validation and laboratory methods used in GLP• Administer Clinical Quality System training and ensure the program meets relevant regulatory requirements• Provide direction and guidance to study teams to address quality issues, concerns, and potential regulatory compliance risks• Maintain awareness and develop expertise of GxP requirements related to clinical research• Serve as clinical quality subject matter expert (SME) for regulatory inspections• Assist with audit and inspection activities (preparation, conduct, and response) for clinical regulatory inspections (internal and at investigator sites)• Provide regular updates to senior management and participate in the resolution of quality issues in clinical research• Provide leadership in cross-functional teams to identify and address compliance risk areas related to clinical research• Implement, perform, and maintain clinical quality systems

Schedule, personally conduct and/or manage external resources, for Global Good Clinical Practice (GCP) and CFR/Annex Part 11 audits which will support Clinical Development activities including but not limited to:• Develop risk based audit planning focusing on medical care of patients and adherence to protocols and GCPs for global clinical site audits• Provide management oversight for and participate in Internal Clinical Development, Biometrics and Medical Affairs Audits• Develop specific audit plans, review and assess internal and external audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices• Collaborate with the appropriate Clinical Development team in follow-up to clinical site audits to ensure resolution of audit findings in accordance with industry best practices• Provide follow-up corrective action with proposed and contracted vendor services• Assist with the maintenance of tracking systems for all GCP audit activity and provide periodic metrics• Provide input to management for new and ongoing systems development• Assist management in the preparation and conduct of regulatory agency inspections

Assisting in the development of the Quality Management SystemParticipating in the Regulatory Intelligence processConducting Internal and External AuditsHosting Sponsor AuditsDeveloping training materials on Standard Operating Procedures and applicable regulationsProviding GCP support to the Clinical Operations Teams

Contribute to the maintenance of high quality and compliance status of all products handled by Sanofi Canada to meet all Canadian cGMP requlations as well as Corporate requirements.