Director, Quality, Safety

7 months ago

Mississauga, Canada Specialty Health Network Inc. Full time

**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?**

Reporting directly to Senior Director, Quality Assurance, the incumbent will be responsible strategic leadership and functional management of quality, regulatory, safety 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 quality 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, Quality Assurance, Safety & Compliance plays a pivotal role in supporting development of business strategy and provides direction in establishing and maintaining the quality systems and standards in compliance with established procedures, relevant regulations, client requirements and industry guidelines.
- Maintain the SHN Quality Management System (QMS) in compliance with all Drug Establishment License (DEL), Medical Device Establishment (MDEL) and Patient Support Program (PSP) requirements.
- ** Internal/External Quality/Regulatory Audits**:

- Ensure a state of audit readiness at all times
- Lead/support all quality, regulatory and customer audits & inspections of SHN
- Oversee timely completion of corrective/preventive actions and closure of audit records
- ** Supplier Quality Management**:

- Ensure that SHN suppliers and vendors are qualified and approved Quality Agreements are established and maintained
- Develop, execute, and implement Pharmacovigilance Agreements, including reviewing of Master Service Agreement (MSA) and Scope Of Work (SOW) documents
- Support negotiation of technical Quality Agreements with suppliers for approval
- ** Validation Program/Qualification**:

- Ensure that SHN processes/equipment/computerized systems/transportation & packaging are appropriately validated and/or qualified in compliance with relevant regulations and standards.
- ** Non-conformances/Deviations/CAPAs**:

- Provide oversight of Product Hold/Quarantine/Reject processes
- Ensure that Non-conformances/Deviations/CAPAs are initiated, investigated, and closed on time and that CAPAs are effective
- ** Document/Record Management**:

- Identify and review government, regulatory and corporate policies to ensure all procedures are current and meet requirements
- Identify compliance gaps, develop, and implement plans to address
- Update/Develop SOPs ensuring timely implementation
- Ensure the SHN Quality document management system and associated records are reviewed, maintained and organized
- ** Personnel Training**:

- Ensure that SHN personnel are trained on GMPs and QMS procedures
- Manage timely completion of direct reports personnel training and training records
- ** Post Market Surveillance**:

- Provide pharmacovigilance oversight of Patient Support programs and any other initiatives which may generate AE information
- Maintain accountability for quality of data generated, and PV activities performed by PV personnel
- Support development and execution of FCA/Recalls (as required)
- Support product complaint investigations and reporting (as required)
- ** Regulatory Affairs**:

- Support the maintenance of establishment licenses issued by Health Canada
- ** Management Review Meetings**:

- Lead management review meeting(s) for SHN, reporting on compliance status of QMS activities, identification of issues/negative trends and/or risks. Define necessary actions with key stakeholders.
- Report on status of quality goals and metrics
- ** Provide leadership to direct reports**:

- 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
- ** Project Management**:

- Support/Lead projects with quality/regulatory impact
- Determine and timely execute/implement quality requirements per plan
- ** Other**:

- Act as the Privacy Officer for SHN 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 an

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