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: 243 Consumers Road, Toronto, Ontario, M2J 4W8 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? Reporting directly to Director, Quality Assurance, the incumbent will be responsible for quality and regulatory management oversight of the enterprise front shop health products, eCommerce, and validation program in compliance with Canadian laws and Health Canada regulations and guidelines. As part of the central office Quality Assurance team, you will also provide additional regulatory consulting to: EPG, PC Health and Space Planning as required. Duties: Working closely with internal teams and suppliers, the Manager, Quality Assurance will provide leadership in establishing and maintaining the quality systems and standards specific to front shop, eCommerce, health products classified as drugs, natural health products and medical devices and validation program with quality/regulatory impact.

• Regulatory Consulting support:
  • Goods Not For Retail (GNFR), PC Health, Space Planning to ensure no activities impact enterprise establishment licenses
  • EPG (Enterprise Procurement Group), PC Health, Space Planning, to ensure timely regulatory review of GNFR articles, and no activities impact enterprise establishment licenses
  • On a case-by-case basis, support PC Health, Space Planning ensuring any vendor (manufacturer/importer/distributor) marketing and advertising material is approved by Health Canada prior to appearing on e-commerce websites
• Change Control (Internal and External)
  • Manage the change control processes for:
    • Article create/listing/de-listing/changes to existing articles in the master database - front shop
    • Reclassification of article categories/fine lines in the master database
    • Assigns/Verifies front shop Pharmacy Schedules in accordance with the National Drug Schedules and each Provincial Drug Schedules Regulation
    • MicroStrategy Listing Reports
    • Process/Equipment/Computerized Systems/Supplier/Material with quality and regulatory impact
    • Work closely with the following teams:
      • Data Operations to ensure data integrity
      • Merchandizing category, eCommerce, to ensure timely regulatory review of front shop articles/health products
      • Customs Compliance to support the business requirements and ensure compliance to regulatory requirements for the importation of health products
      • IT teams to assess quality/regulatory impacting computerized systems and changes to existing systems requiring validation/re-validation
      • Approved 3rd party logistics to ensure validation compliance of the warehouse sites, their equipment, cold chain pack-outs, computerized systems, and others, where applicable
  • Manage the QA processes to maintain the regulatory fields in the master database (SAP) for front shop articles
  • Manage the review and performance of quality/regulatory impact assessment of changes to validated computerized system
  • Manage timely completion and closure of change requests
• Internal/External Quality/Regulatory Audits
  • Manage the health product audit program for front shop distribution centers/warehouses
  • Audit related front Shop service suppliers
  • Provide support to warehouse sites to maintain site precursor licenses in compliance, as required
  • Manage the auditing of SDM eCommerce sites e.g., SDM.ca, PCX
  • Oversee timely completion of corrective/preventive actions and closure of audit records
  • Support Precursor/other regulatory (e.g., Health Canada) inspections with the Director, QA and Sr. Director QA
• Management of the eCommerce - Quality Assurance
  • With assigned direct report/s, oversee the Quality Assurance activities for eCommerce, ensuring any vendor (manufacturer/importer/distributor) marketing and advertising material is approved by Health Canada prior to appearing on e-commerce websites
  • Oversee regular audits of the online platform products to ensure regulatory compliance with National Pharmacy Regulations and Standards in the respective provinces and federal regulation requirements
  • Provide oversight ensuring only quality assurance approved products are listed to the eCommerce platforms
• Supplier Quality Management
  • Responsible for qualifying front shop vendors, distribution sites, transport providers and ensuring establishment of Quality Agreements, as required
  • Support negotiation of technical Quality Agreements with suppliers for approval
• Validation Program/Qualification:
  • Manage the development and execution of Validation Master Plan and validation protocols
  • Review and approve validation protocols and reports
  • Manage Process/Equipment/Computerized Systems/Transport Lane mapping studies
  • Support the execution of cold chain pack-out performance qualification by coordinating the issuance of internal store communication
  • Manage timely completion of validation/re-validation activities
• Non-conformances/Deviations/CAPAs:
  • Provide oversight of Product Hold/Quarantine/Reject process for front shop health products
  • Manage the communication with the suppliers in obtaining product stability information or requesting product stability assessment
  • Provide product disposition to distribution center QA in the event of product impacting temperature excursion
  • Ensure that Non-conformances/Deviations/CAPAs are initiated, investigated, and closed on time

• Document/Record Management:
  • Review government, regulatory and corporate policies to ensure all procedures are current and meet requirements for front shop health products
  • Identify compliance gaps, develop and timely implement plans to address compliance gaps
  • Manage document and record compliance for front shop products at the Distribution Centers
  • Develop/Revise SOPs for implementation at the distribution centers
• Returned Products
  • Manage the QA processing for front shop products returned products and associated documentations and provision of product disposition
• Personnel Training
  • Conduct personnel training on GMPs and SOPs
  • Manage timely completion of direct reports personnel training and training records
• Management Review Meetings
  • Report on the status of front shop and eCommerce distribution center Quality Systems to Director, QA
  • Present and participate in the quality management review meetings
  • Prepare monthly and annual reports on quality metrics
• Provide leadership to direct reports
• Others:
  • Support of other Healthcare businesses, as required
  • Perform other Quality duties, as assigned
  • Occasional travel to various distribution centers and vendor sites, as required

Skills and Experience: This position requires an advanced level of initiative and judgment in order 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 7 years working in the GMP pharmaceutical industry in Quality Assurance
• Must have a Bachelor of Science degree (or Canadian Equivalent)
• Must have a strong validation experience - writing, execution and reporting
• Strong understanding and sound interpretation of Health Canada GMP and other related guidelines, Medical Device Regulations, Natural Health Product Regulations, the Narcotic Controlled Regulations, Controlled Drugs and Substances Act, Benzodiazepine and Other Targeted Substances Regulations, Precursor Control Regulations, Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances)
• Strong Quality and risk-based approach decision making and business acumen
• Quality Auditor Certification and audit experience an asset
• Regulatory Affairs, Supply Chain and Logistics experience, 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.
• Utilizes decision making skills to achieve specific organizational objectives with consideration given to their impact on other work groups.
• Adaptable to set and prioritize work with varying exceptions. Able to work with diverse personalities and styles.
• Advanced understanding of Quality Assurance policies and procedures in a manufacturing and supply chain/logistics environment
• Ability to handle sensitive issues requiring timely completion of documentation to control deficiencies and expedite product dispositions
• Sound knowledge of compliance and regulatory components, auditing skills, and quality systems
• Interpret Health Canada GMPs and other Guidelines and regulations, PIC/s, corporate policies/standards to determine SDM position regarding quality processes, 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 with clarity, verbally to conduct personnel training and in one on one or group situations, or over the telephone.
• 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.