Manager, Quality Assurance

Location:

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?

Manager, Quality Assurance [Rx Transport]

Reporting directly to Director, Quality Assurance, the incumbent, as an independent contributor, will be responsible for quality management oversight of transportation activities related to drug wholesale, natural health products and medical device distribution for the pharmaceutical sourcing and commercial operations 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 health products (i.e. drugs, natural health products, medical devices).  

• Internal/External Quality/Regulatory Audits:

• • Manage the outbound 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 health product 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 health product transport suppliers and related service suppliers with support from the Sr. Director/Director, QA. 

• Validation/Qualification:

• • Ensure that all transport related software solutions are validated to the drug wholesale, natural health products 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 health products transport condition requirements.

• Non-conformances/Deviations/CAPAs:

• • Manage the communication with the suppliers in obtaining closures of corrective and preventive actions.

  • Provide direction, with support from the 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 with training records maintained 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 supplier sites, as required

Skills and Experience:

This position requires an advanced level of initiative, Rx Drug/NHP/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 an ability to apply concepts and theories to improve functions or units.

• Requires specialized interpersonal skills to resolve situations with colleagues where there may be some level of conflict, stress or uncertainty

• Provides solutions by using imaginative approaches where constructive and critical thinking and innovation are required

• Utilizes decision making skills to achieve specific organizational objectives with consideration given to their impact on other work groups.

• Adaptable to set and prioritize work with varying exceptions.  Able to work with diverse personalities and styles.

• Advanced understanding of Quality Assurance policies and procedures in a manufacturing and supply chain/logistics environment      

• Ability to handle sensitive issues requiring timely completion of documentation in order to control deficiencies and expedite product dispositions

• Sound knowledge of compliance and regulatory components, auditing skills, and quality systems

• Interpret Health Canada GMPs and other Guidelines and regulations, PIC/s, corporate policies/standards to determine SDM position regarding quality processes, compliance requirements

• Maintaining quality and patient safety first while recognizing the importance of good business decisions      

• Computer skills to produce effective reports, documents, spreadsheets and presentations.

• Communicates with clarity, verbally to conduct personnel training and in one on one or group situations, or over the telephone

• Communicates well in writing by composing clear documents      

• Able to work with minimal of supervision.  

• Proficient in all Microsoft Office applications (especially Excel, Word and PowerPoint)

Why work at Shoppers Drug Mart?

Acting as consultants, supporting internal customers and the Associate-Owners, you will get experience unique to the retail industry while working for an award-winning national brand.   Benefit from a purchase discount program, competitive pay and online learning through Academy.

Take ownership of your work and find more ways to care about your work, co-workers, customers and community.

How You'll Succeed:

At Shoppers Drug Mart Inc., we seek great people to continually strengthen our culture.  We believe great people model our values, are authentic, build trust and make connections. 

If that sounds like you, and you are open-minded, responsive to change and up to the challenges provided in a fast-paced retail environment, apply today. 

Employment Type:

Type of Role:

Shoppers Drug Mart Inc. recognizes Canada's diversity as a source of national pride and strength. We have made it a priority to reflect our nation's evolving diversity in the products we sell, the people we hire, and the culture we create in our organization. Accommodation is available upon request for applicants with disabilities in the recruitment and assessment process and when hired.

In addition, we believe that compliance with laws is about doing the right thing.  Upholding the law is part of our Code of Conduct – it reinforces what our customers and stakeholders expect of us.

Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.

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