Manager, Quality Assurance

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.

Basic Function

Reporting directly to the Director, Scientific Affairs & QA, the Manager, Quality Assurance is responsible to lead the Quality team ensure compliance and efficient day-to-day quality operations.

Nature and Scope

In this position, the Manager, Quality Assurance is responsible for maintaining the compliance with the GMP Regulations as they relate to pharmaceutical and importation, distribution and/or wholesaling activities, including but not limited to: product quality complaints, non-conformance investigations, product release/disposition, recalls, training, third party audits, change control, self-inspections, CAPA management, validation of critical processes, qualification of equipment/facilities/vendors, operational complaint investigations, and product dossier compliance. In addition, this individual must ensure compliance with corporate standards and business quality practices.

Principal Accountabilities

• Provides leadership in establishing and maintaining quality and risk management, including the development and implementation of required Standard Operating Procedures (SOPs)
• Manage and lead all Regulatory (ex. Health Canada) inspections
• Manage and maintain current all required Regulatory licenses (ex. DEL, MDEL, etc.)
• Manage and lead all required Third Party Audit requests and maintain third party documentation (ex. Quality Agreements, MSDS)
• Manage regulatory and corporate audit commitments.
• Perform any required Vendor audits and other qualification requirements (ex. Quality Agreements)
• Internal GMP Self Inspection: Audit and report on the Quality Management System to ensure its ongoing effective application
• Manage the execution of critical process Validation, equipment/facilities/software qualification
• Manage and oversee product/device storage requirements and associated monitoring systems
• Execute the Investigation Program for various categories of events
• Manage and oversee the Product Release process and in a backup capacity, perform product release duties
• Manage and oversee the Product Quarantine/Reject process
• Develop, review and maintain current SOPs
• Oversee the Product Quality Complaint Program
• Manage and coach staff members within the QA team
• Develop the QA work unit’s performance indicator systems and the analysis of established objectives
• Determine, as needed, the necessary actions to streamline efficiency
• Communicate the necessary information to keep the team and the Senior Director, Quality Assurance abreast of work plan, projects, processes, results, actions and recommendations
• Represent the Quality Department, both internally and externally, as a subject matter expert and source for consultation and/or information and/or reference
• Acts as the delegate in the absence of the Senior Director, Quality Assurance
• Manage and oversee employee Training status and documentation for SOPs and operational procedures during the absence of Manager, Quality Training.
• Work with Department Managers to ensure that there are appropriate levels of training, education & coaching on GMP management systems for all disciplines of the workforce during the absence of Manager, Quality Training
• Schedule and facilitate quarterly Quality Management Review meetings, present topics which cover quality goals with main emphasis on Key Performance Indicators (KPI’s) applicable to quality system elements.

Qualifications and Skills

• B.Sc. degree in Chemistry, Pharmacy, Biology, Chemical Engineering, Microbiology or a similar discipline
• Minimum of Seven to Ten (7-10) years Quality management experience in a pharmaceutical manufacturing setting, at least 2 in a direct Management role
• Extensive current knowledge and experience with cGMP and Medical Device Regulations
• Minimum five (5) years of GMP Auditing experience
• MRA, ICH, WHO, ISO 9001/9002/13485 knowledge and understanding
• Validation and Qualification (process, software, equipment, facilities) experience
• Demonstrated effective Management Skills
• Strong computer knowledge: Microsoft Office, Database Management, Inventory Control
• Excellent communication skills, both written and oral, are required
• Excellent time management, interpersonal and organizational skills, with a strong attention to detail
• A team player with the ability to work well with other departments within SDMSHN as well as with third parties and other SDM Divisions/affiliates.

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: 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.