Director, Scientific Affairs & Quality Assurance

Referred applicants must not apply directly to this role. All referred applicants must use their unique referral link generated when they are referred by an existing colleague. Location: 1685 Tech Ave, Mississauga, Ontario, L4W 0A7 At Shoppers Drug Mart, we’re innovating health and wellness in Canada. From prescriptions to walk-in clinics, and a beloved loyalty program, we’re caring and supporting our customers in new ways every day. With more than 1,300 locally owned and operated stores from coast to coast, the Shoppers Drug Mart network is more than a great place to shop, it’s a great place to work. We’re committed to building our talented team who champion collaboration, kindness and inclusivity. Join our team, and help recognize a healthy future for your career and for all Canadians. Why this role is important? 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. Duties: As an active member of the Specialty Health Network leadership team, the Director, Scientific Affairs & Quality Assurance plays a pivotal role in supporting development of business strategy and provides audit leadership, pharmaceutical client Pharmacovigilance leadership, and direction in establishing and maintaining the quality management system in compliance with established procedures, relevant regulations, client requirements and industry guidelines. Quality Assurance Oversee maintenance and submission of establishment licences, including Drug Establishment Licenses (DEL) and Medical Device Establishment Licences (MDEL) for the SHN portfolio. This includes, but is not limited to application for new licenses, revision or changes to existing licences, and annual license renewals. Oversee intake and analysis of new and revised regulations and standards for impact to established procedures impacting the SHN Quality Management System (QMS). Support consultation activities and work with key stakeholders to define risks and action plans as required. Oversee the SHN Quality Management System, ensuring a state of audit readiness at all times. This includes, but is not limited to: Document Control & Lifecycle Management, Vendor Qualification, Nonconformance & CAPA Systems, Change Control, Self-Inspection & Audit Lifecycle Management, Validation & Qualification, Post-Market Surveillance activities, and oversight of the SHN warehouse storage/distribution/transport logistics activities Patient Support Program (PSP) Leadership & Compliance Act as advisor on all Pharmacovigilance and Patient Safety matters to support maintenance of existing Patient Support Programs (PSPs) Act as primary client point of contact for all matters related to Pharmacovigilance and Patient Safety Engage with PV leadership at pharmaceutical client companies Participate in RFPs for new business / PSP programs Ensure that client requirements established for each PSP are achieved in full compliance. This includes working with key stakeholders to ensure requirements for documentation, training, AE reporting, record retention and associated system validation(s) are established and maintained. Maintain Key Performance Indicators by program Lead client PSP audits and associated lifecycle management activities Pharmacovigilance Oversee the Pharmacovigilance team for all business units within the Healthcare Businesses portfolio, ensuring that post-market adverse event reporting requirements are maintained in full compliance with regulatory requirements. Ensure that AEs / ADRs are reported to Patient Support Program (PSP) clients per established PV agreements and/or to Health Canada in accordance with the Food and Drug Regulations Maintain Pharmacovigilance Agreements with clients and vendor services. Ensure validated systems are in place and maintained for recording, evaluating, and tracking of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Accountable for drug vendor / PSP Client and Global Pharmacovigilance compliance inspections / audits Patient Safety Compliance Act as the Privacy Officer for Patient Support Programs (PSPs) to provide oversight and guidance on all matters related to privacy and medication incident management compliance. Work closely with members of the Privacy Office, Enterprise Pharmacy Continuous Improvement and Pharmacy Professional Affairs to ensure compliance. Personnel Leadership Champion the enterprise Vision, Mission, and Values to foster high colleague engagement and a ground-up culture of accountability, collaboration and continuous improvement Coach / mentor direct and indirect reports Other: Create and support process enhancement initiatives to maintain an environment of continuous improvement Occasional travel to various company sites / distribution centers and/or vendor sites, as required Skills and Experience: This position requires an advanced level of initiative and judgment to organize and prioritize tasks, workload and projects. A strong ability to influence while maintaining courtesy, tact and diplomacy is required in dealing with direct report/s and colleagues in every day working relationships. Minimum 10+ years working in the GMP pharmaceutical industry with progressive experience in Quality Assurance disciplines Must have a Bachelor of Science degree (or Canadian Equivalent) Must have previous people leadership experience with a demonstrated ability to effectively lead large teams Must have demonstrated experience leading regulatory inspections and customer audits (e.g., Health Canada) Must have demonstrated experience in warehouse storage/distribution/transportation logistics Proficient understanding and sound interpretation of Health Canada GMP, GVP and other related guidelines, Medical Device Regulations, and Natural Health Product Regulations Strong Quality and risk-based approach decision making and business acumen Experience working in large, matrix organizations and demonstrated ability to communicate effectively across all levels of an organization Strong negotiation, influencing and problem-solving skills Leadership presence, with confidence to engage and influence internal and external stakeholders Quality Auditor Certification and audit experience an asset Experience / knowledge of Patient Support Programs (PSPs) an asset Additional Skills and Experience: Requires an ability to apply concepts and theories to improve functions or units. Requires specialized interpersonal skills to resolve situations with colleagues where there may be some level of conflict, stress or uncertainty. Provides solutions by using imaginative approaches where constructive and critical thinking and innovation are required. Adaptable to set and prioritize work with varying exceptions. Able to work with diverse personalities and styles. Ability to handle sensitive issues requiring timely completion of documentation to control deficiencies and expedite product dispositions Interpret Health Canada GMPs, GVPs and other Guidelines and regulations, PIC/s, corporate policies/standards to determine company position regarding regulatory & pharmacovigilance processes and compliance requirements Maintaining quality and patient safety first while recognizing the importance of good business decisions Computer skills to produce effective reports, documents, spreadsheets, and presentations. Communicates well in writing by composing clear documents Able to work with minimal of supervision. Proficiency in all Microsoft Office applications (especially Excel, Word and PowerPoint) Why work at Shoppers Drug Mart? Acting as consultants, supporting internal customers and the Associate-Owners, you will get experience unique to the retail industry while working for an award-winning national brand. Benefit from a purchase discount program, competitive pay and online learning through Academy. Take ownership of your work and find more ways to care about your work, co-workers, customers and community. How You’ll Succeed: At Shoppers Drug Mart Inc., we seek great people to continually strengthen our culture. We believe great people model our values, are authentic, build trust and make connections. If that sounds like you, and you are open-minded, responsive to change and up to the challenges provided in a fast-paced retail environment, apply today. Employment Type: Full time Type of Role: Regular Shoppers Drug Mart Inc. recognizes Canada's diversity as a source of national pride and strength. We have made it a priority to reflect our nation’s evolving diversity in the products we sell, the people we hire, and the culture we create in our organization. Accommodation is available upon request for applicants with disabilities in the recruitment and assessment process and when hired. In addition, we believe that compliance with laws is about doing the right thing. Upholding the law is part of our Code of Conduct – it reinforces what our customers and stakeholders expect of us. Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application. #J-18808-Ljbffr