Specialist, Quality Assurance

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?
The Specialist, Quality Assurance is responsible for developing, implementing, and maintaining the enterprise Quality Management Systems. This role supports the businesses in ensuring compliance with Canadian laws and Health Canada regulations and guidelines applicable to health products, including drugs, medical devices, and natural health products. The incumbent will work closely with enterprise Operations, other internal stakeholders, and external supplier.

Duties and Responsibilities
Quality Management System (QMS) Establish & Maintenance

Provide support in the establishment, implementation, and maintenance of quality systems.

Develop, author, and implement required Standard Operating Procedures (SOPs).

Maintain regulatory licences (e.g., MDEL, DEL).

Identify and review applicable government, regulatory, and corporate policies to ensure all procedures are current and meet requirements; identify compliance gaps, and develop and implement plans to address them.

Ensure all respective personnel are trained and qualified on GMPs, complaint handling, and relevant SOPs.

Perform regular visits to sites/distribution centers.

Product Quality Control & Disposition

Oversee the Product Quarantine/Reject process at the site/distribution center.

Liaise between suppliers and distribution centers to obtain product stability information/assessment.

Issue product disposition in the event of temperature excursions impacting or potentially impacting products.

Evaluate returned products and associated documentation, and provide product disposition.

Non‑Conformances & Corrective/Preventive Actions (CAPA)

Write and investigate CAPAs when non‑conformances occur, utilizing Root Cause Analysis.

Ensure timely completion and closure of Non‑conformances/Deviations/CAPA reports.

Document & Record Management

Identify and review applicable 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 and organize all quality documents.

Change Control (Internal & External)

Review and process change requests for product creation, listing, and de‑listing.

Review/Provide/Approve quality and regulatory impact assessments on process/equipment/supplier/material change requests.

Audits & Inspections

Conduct internal and external audits, prepare reports, and follow up on identified issues, ensuring timely completion of corrective/preventive actions and closure of audit reports.

Perform 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 Director QA and Sr. Director QA.

Product Complaints Management

Track and report product complaints to suppliers and follow up on corrections/corrective actions as needed.

Investigate product complaints as required.

Liaise for effective processing of complaints and return of complaint samples to suppliers as needed.

Communicate corrections/corrective actions by supplier internally and to the site/distribution center as needed.

Supplier Quality Management

Support supplier and/or material qualification (e.g., vendor audits, establishment of Quality Agreements, product review/assessment).

Support the development and maintenance of Quality Agreements with suppliers.

Validation & Qualification

Support the execution of the Validation Master Plan and validation protocols (e.g., process,…