Manager, Quality Assurance

3 weeks ago

Toronto, Canada Shoppers Drug Mart Pharmaprix Full time

**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 _Senior Director, Quality Assurance _, the incumbent, as an independent contributor, will be responsible for quality management oversight of RX Quality Assurance transportation activities related to Drug Wholesale/Distribution and Medical Device Distribution for the pharmaceutical partnerships team.

**Duties**:
Working closely with Quality Assurance departments within the Healthcare Businesses, pharmaceutical partnerships, and supply chain operations, the Manager, QA [RX Transport] will provide leadership in establishing and maintaining the transport quality systems and standards specific to drug products and medical devices.
- **Internal/External Quality/Regulatory Audits**:

- Manage the outbound [and inbound as applicable] transport service supplier regulatory qualification and audit program, by maintaining a qualification framework for service suppliers [questionnaires, audits, CAPAs etc.]
- Track and manage all Corrective and Preventive Actions identified during audits, and support documenting evidence of resolution according to regulatory good documentation practices.
- Support Regulatory quality team with external pharmaceutical partnerships drug/medical vendor audits.
- Support regulatory quality team with Health Canada audits.
- **Supplier Quality Management**:

- Incumbent will be responsible for qualifying other related service suppliers: temperature monitoring, preventive maintenance, validation consultants etc.
- **Legal technical Agreements**:

- Lead technical quality agreement negotiations with RX transport suppliers and related service suppliers with support from the Sr. Director, QA.
- **Computerized System Validation/Qualification**:

- Ensure that all transport related software solutions are validated to the drug wholesale and medical device distribution requirements.
- Ensure transport monitoring devices are calibrated i.e. NIST traceable]; and certificates are maintained.
- Ensure transport reefers are qualified to support transport of pharmaceuticals and medical devices
- **Non-conformances/Deviations/CAPAs**:

- Manage the communication with the suppliers in obtaining closures of corrective and preventive actions.
- Provide direction, with support from the Sr. Director QA on transport temperature excursions
- Ensure that Non-conformances/Deviations/CAPAs are initiated, investigated and closed on time
- **Document/Record Management**:

- Create/Revise SOPs for implementation for the transport quality management system
- **Personnel Training**
- Conduct personnel training on GMPs and SOPs, and ensure contract transport colleagues also receive the appropriate training and document per GDP
- Track timely completion of personnel training and manage personnel quality training records
- **Management Review Meetings**
- Prepare and present transport quality assurance metrics, issues, and risks in periodic management review meetings.
- **Others**:

- Support of other Healthcare businesses, as required
- Occasional travel to various distribution centers and vendor sites, as required

**Skills and Experience**:
This position requires an advanced level of initiative, RX Drug/Medical Device experience, 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 5+ years working in the GMP pharmaceutical industry in regulatory Quality Assurance
- Minimum 2+ years working in a medical device industry in regulatory 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 drug 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
- Strong Quality and risk-based approach decision making and business acumen

**Additional Skills and Experience**:

- Requires specialized interpersonal skills to resolve situations with colleagues where there may be some level

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