Manager, 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?**

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 computerized systems validation 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 of computerized systems 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
- 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 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, to 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/Qualification:

- Manage the development and execution of Validation Master Plan and validation protocols
- Review and approve validation protocols and reports
- Manage Process/Equipment/Computerized Syst