Regulatory Affairs à United States

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.

Reporting directly to the Vice President, Pharmaceutical Sourcing and Commercial Operations, the incumbent will be responsible for Management oversight of Quality and Regulatory activities.

The Senior Director, Quality Assurance will deliver the following:

• Provides leadership in establishing and maintaining the Quality Management Systems and Risk Management programs at SDM Inc., including the:
• Development and implementation of required Standard Operating Procedures (SOPs)
• Support all Regulatory (ex. Health Canada) inspections
• Manage and maintain current all required Regulatory licenses (ex. SDM DEL, SDM MDEL, NBCP Wholesale License etc.)
• Oversight over Health Product licensed facilities:
• Oversight over the Import Drug Products Quality Management System
• Management of the Health Canada required Computerized System Validation process
• Oversight over the Quality Management System for SDM E-Commerce site
• Management of SAP Master Data:
  • Pharmacy Schedules within SAP
  • All Drug, Medical Device, and NHP attributes
• Manage and lead all required Third Party Audits
• Perform any required Vendor audits and other qualification requirements (e.g., Quality Agreements)
• Internal GMP Self Inspection: Audit and report on the GMP management system to ensure its on-going effective application
• Oversight of the Product Quality Complaint Program
• Occasional travel to the various SDM sites will be required

Quality and Regulatory management oversight with applicable Business units:

• Shoppers Drug Mart
• Medisystem Pharmacy
• Central Pharmacy Services
• Sanis Inc.
• Specialty Health Network

This position requires an advanced level of initiative 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 colleagues in everyday working relationships.

• Minimum 15 years working in the GMP pharmaceutical industry in Quality Assurance
• Experience working in the Medical Device
• Must have a Bachelor of Science (or Canadian Equivalent)
• Supply Chain and Logistics experience an asset

• Requires an ability to apply concepts and theories to improve functions or units.
• Manages a function or unit by focusing on achievement of objectives.
• 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 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 environment
• Sound knowledge of compliance and regulatory components, auditing skills, and quality systems.
• Computer skills to produce effective reports, documents, spreadsheets, and presentations.
• Communicates with clarity, verbally and in one-onone or group situations, or over the telephone
• Communicates well in writing by composing clear documents; facility with editing and/or proof-reading is required
• Proficiency in all Microsoft Office applications (especially Excel, Word and PowerPoint)

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.

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: Full time

Type of Role: Regular

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.