Senior Specialist, Quality Assurance

Supplier Quality

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.

Reporting directly to Director, Quality Assurance, the incumbent will be responsible for implementing and maintaining the enterprise Quality Systems and supporting the distribution centers ensuring compliance with Canadian laws and Health Canada regulations and guidelines applicable to drugs, medical devices and natural health products. This includes reviewing documents, evaluating returned products, providing product disposition, developing SOPs, risk assessment and management, auditing, validation, change control, non‑conformances, CAPAs, maintaining regulatory licenses, etc.

• Document/Record Management:
  • Review government, regulatory and corporate policies to ensure all procedures are current and meet requirements
  • Identify compliance gaps, develop and implement plans to address compliance gaps
  • Update/Develop SOPs ensuring timely implementation
  • Maintain organization of all quality documents
• Change Control (Internal and External)
  • Review and process change requests for product create/listing/de‑listing
  • Review and provide quality and regulatory impact assessment on process/equipment/supplier/material change requests from SDM Operations and distribution centers
  • Update metrics
• Non-conformances/Deviations/CAPAs:
  • Support the oversight of Product Quarantine/Reject process at Distribution Centers
  • Liaise between suppliers and distribution centers in obtaining product stability information/assessment from suppliers and issuing product disposition to distribution center QA in the event of temperature excursion impacting/potentially impacting products
  • Write CAPAs when non‑conformances occur
  • Provide support by reviewing and ensuring timely completion and closure of Non-conformances/ Deviations/CAPAs reports
  • Review, track and trend deviations/non-conformances/CAPAs
• Internal/External Quality/Regulatory Audits
  • Conduct internal and external audits, prepare report and follow‑up on issues identified ensuring timely and 100% completion of corrective/preventive actions
  • Internal GMP Self Inspection:
    Audit and report on the GMP management system to ensure its ongoing effective application
  • Support Regulatory (e.g. Health Canada) inspections with the Sr. Manager QA and Sr. Director QA
  • Track closure of audit commitments
• Product Complaints
  • Track and timely report product complaints to suppliers and follow‑up on corrections/corrective actions, as needed
  • Liaise effective processing of complaints and return of complaint samples to suppliers, as needed
  • Communicate corrections/corrective actions by supplier internally and to distribution center QA, as needed
• Supplier Quality
  • Support supplier and/or material qualification (e.g. vendor audits, establishment of Quality Agreements, product review/assessment)
  • Maintain copies of current suppliers’ regulatory licenses (i.e. DEL, MDEL, Narcotic, Precursor, Authorized Personnel) - annual
• Returned Products
  • Evaluate returned products and associated documentation and provide product disposition
• Validation/Qualification
  • Write and execute Validation Master Plan and validation protocols (e.g. process, equipment, facilities, software qualification, material qualification, etc.)
  • Analyze validation results and write validation final reports
  • Review validation protocols and reports
  • Follow‑up on completion of validation/re‑validation
  • Conduct seasonal transport lane temperature profile studies
• Personnel Training
  • Conduct personnel training on GMPs and SOPs
  • Track timely completion of personnel training and manage personnel quality training records
• Management Review Meetings
  • Report…