Job Description

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 Values
• As 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 SHN
• Lead the SHN Pharmacovigilence and Quality Assurance teams while liaising with partners
• Establish and oversee the SHN Quality, Safety and Compliance 5-year+ Roadmap
• Identify current and emerging regulatory changes that impact quality and safety governance and evolve responsive strategies
• Lead the evolution of a culture of compliance
• Provide strategic leadership on all PV activities to support Patient Support Programs
• Act as advisor to senior leadership on Safety, Quality and Compliance matters
• Ensure that SDM SHN Quality Systems are implemented and comply with GMP regulations and PSP requirements
• Serve as the site Quality Assurance and Safety liaison with external clients and regulatory agencies
• Provide 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 program
• Provide 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 Affairs
• Ensure 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 stakeholders
• Promote activities to foster quality and safety compliance awareness across the organization
• Drive alignment and commitment at all levels of the organization to promote compliance
• Develop, execute, and implement Pharmacovigilance and Quality Agreements, including reviewing of MSA and SOWs
• Support the acquisition of new business/RFPs
• Provide guidance and support to define, track and report on department Key Performance Indicators
• Drive solutions for risk mitigation in collaboration with Management, and stakeholders across the organization
• Lead 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 plans
• Provide pharmacovigilance oversight of Patient Support programs and any other initiatives which may generate AE information
• Maintain accountability for quality of data generated, and PV activities performed by PV personnel
• Conduct oversight meetings with Patient Support program teams, maintaining effective business relationships and tracking performance metrics
• Maintain 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 processes
• Deliver effective communications, both verbal and written
• Lead, manage and develop the SHN Quality, Safety and Compliance team
• Establish and manage to short and long term departmental objectives, policies, operating procedures, and annual budgets
• Foster high colleague engagement and a ground-up culture of accountability, collaboration and continuous improvement

Skills, Experience, & Education

• University degree in sciences (or Canadian Equivalent)
• Deep pharmaceutical expertise in Canada
• Supply Chain experience an asset
• PSP experience an asset
• Minimum 10+ years experience leading quality assurance in the GMP Pharmaceutical Industry
• Proficient 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 pharmacovigilance
• Established relationships with regulatory bodies (e.g., Health Canada)
• Supply Chain and Logistics experience an asset
• Knowledge of retail or specialty pharmacy an asset
• Experience working in large, matrix organizations and making timely and effective decisions in a rapidly evolving market
• Strong negotiation, influencing and problem-solving skills
• Leadership presence, with confidence to engage and influence internal and external stakeholders
• Strong team leadership and ability to build and maintain effective cross-functional relationships
• Excellent communication across all levels of respective teams and across the enterprise
• Ability to coach and mentor others
• Adaptable 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 level
• Flexibility to travel (

10%)
Our commitment to Sustainability and Social Impact is an essential part of the way we do business, and we focus our attention on areas where we can have the greatest impact. Our approach to sustainability and social impact is based on three pillars - Environment, Sourcing and Community - and we are constantly looking for ways to demonstrate leadership in these important areas. Our CORE Values - Care, Ownership, Respect and Excellence - guide all our decision-making and come to life through our Blue Culture. We offer our colleagues progressive careers, comprehensive training, flexibility, and other competitive benefits - these are some of the many reasons why we are one of Canada's Top Employers, Canada's Best Diversity Employers, Canada's Greenest Employers & Canada's Top Employers for Young People.
If you are unsure whether your experience matches every requirement above, we encourage you to apply anyway. We are looking for varied perspectives which include diverse experiences that we can add to our team.
We have a long-standing focus on diversity, equity and inclusion because we know it will make our company a better place to work and shop. We are committed to creating accessible environments for our colleagues, candidates and customers. Requests for accommodation due to a disability (which may be visible or invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable opportunities.
Please Note:
Candidates who are 18 years or older are required to complete a criminal background check. Details will be provided through the application process.
#EN #SS #LEGAL #ON

Skills Required