Director, Scientific Affairs

Come make your difference in communities across Canada, where authenticity, trust and making connections is valued – as we shape the future of Canadian retail, together. Our unique position as one of the country's largest employers, coupled with our commitment to positively impact the lives of all Canadians, provides our colleagues a range of opportunities and experiences to help Canadians Live Life Well.At Loblaw Companies Limited, we succeed through collaboration and commitment and set a high bar for ourselves and those around us. Whether you are just starting your career, re-entering the workforce, or looking for a new job, this is where you belong. Director, Scientific Affairs & Quality Assurance Reporting directly to the Senior Director, Quality Assurance, the incumbent will be responsible for strategic leadership and functional management of quality assurance, drug safety / pharmacovigilance and compliance governance at Shoppers Drug Mart Specialty Health Network to ensure compliance with established procedures, relevant regulations, client requirements and industry guidelines.  The incumbent is a proven leader capable of engaging with key stakeholders across all levels of the organization to implement quality requirements and translate business goals into the strategic quality plan.Responsibilities: Champion the Enterprise Vision, Mission and ValuesAs an active member of the Specialty Health Network (SHN) Leadership team, play a key role in the development of business strategy and implementation of the strategic vision for SHNLead the SHN Pharmacovigilence and Quality Assurance teams while liaising with partners Establish and oversee the SHN Quality, Safety and Compliance 5-year+ RoadmapIdentify current and emerging regulatory changes that impact quality and safety governance and evolve responsive strategiesLead the evolution of a culture of complianceProvide strategic leadership on all PV activities to support Patient Support ProgramsAct as advisor to senior leadership on Safety, Quality and Compliance mattersEnsure that SDM SHN Quality Systems are implemented and comply with GMP regulations and PSP requirementsServe as the site Quality Assurance and Safety liaison with external clients and regulatory agenciesProvide expertise to develop, implement, and maintain quality standard operating procedures that are compliant with client requirements, aligned with quality standards, current industry trends and best practices.Ensure that the PV vision and strategy is properly executed and aligned to the client's PV programProvide oversight to SHN privacy and medication incident management compliance, working closely with enterprise leaders in the Privacy Office, Enterprise Pharmacy Continuous Improvement and Pharmacy Professional AffairsEnsure inspection-readiness at all times; provide expertise to support regulatory or customer inspections in all areas of business across the designated business units.Establish effective collaborative relationships with all stakeholdersPromote activities to foster quality and safety compliance awareness across the organizationDrive alignment and commitment at all levels of the organization to promote complianceDevelop, execute, and implement Pharmacovigilance and Quality Agreements, including reviewing of MSA and SOWsSupport the acquisition of new business/RFPsProvide guidance and support to define, track and report on department Key Performance IndicatorsDrive solutions for risk mitigation in collaboration with Management, and stakeholders across the organizationLead the development and implementation of internal CAPA plans related to PV and Quality activities or oversee the development, implementation and execution of any necessary CAPA plansProvide pharmacovigilance oversight of Patient Support programs and any other initiatives which may generate AE informationMaintain accountability for quality of data generated, and PV activities performed by PV personnelConduct oversight meetings with Patient Support program teams, maintaining effective business relationships and tracking performance metricsMaintain compliance and metric reports regarding core Quality functions (recall, quarantine, inbound hold, release requirements, sampling, return disposition, record retention, training, environmental temperature control, pest control, sanitation, preventive maintenance, vendor qualification, etc.)Develop pro-active strategies as preventive measures against potential future issues with systems or processesDeliver effective communications, both verbal and writtenLead, manage and develop the SHN Quality, Safety and Compliance teamEstablish and manage to short and long term departmental objectives, policies, operating procedures, and annual budgetsFoster high colleague engagement and a ground-up culture of accountability, collaboration and continuous improvementSkills, Experience, & EducationUniversity degree in sciences (or Canadian Equivalent)Deep pharmaceutical expertise in CanadaSupply Chain experience an assetPSP experience an assetMinimum 10+ years experience leading quality assurance in the GMP Pharmaceutical IndustryProficient understanding of Medical Device Regulations (e.g. SOR 98/282)Proficient understanding of Drug regulations (e.g. GUI-0001, GUI-0069)Knowledge of Canadian regulatory regimes related to drug handling and pharmacovigilanceEstablished relationships with regulatory bodies (e.g., Health Canada)Supply Chain and Logistics experience an assetKnowledge of retail or specialty pharmacy an assetExperience working in large, matrix organizations and making timely and effective decisions in a rapidly evolving marketStrong negotiation, influencing and problem-solving skillsLeadership presence, with confidence to engage and influence internal and external stakeholdersStrong team leadership and ability to build and maintain effective cross-functional relationshipsExcellent communication across all levels of respective teams and across the enterpriseAbility to coach and mentor othersAdaptable to set and prioritize work with varying exceptions. Able to work with diverse personalities and styles.Self-motivated and resilient, with a positive attitude and high energy levelFlexibility to travel (