Sr. Manager, Quality Assurance

Location:

At Shoppers Drug Mart were innovating health and wellness in Canada. From prescriptions to walk-in clinics and a beloved loyalty program were caring and supporting our customers in new ways every day.
With more than 1300 locally owned and operated stores from coast to coast the Shoppers Drug Mart network is more than a great place to shop its a great place to work. Were 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

Job Title: Sr. Manager Quality Assurance

Reports to: Director Quality Assurance

Department: Sanis Health Inc Quality Assurance

Date Prepared: Dec

Summary

The Senior Manager of Quality Assurance is a critical leadership role responsible for overseeing and advancing the companys Quality Management System (QMS) to ensure the highest standards of product quality safety and regulatory compliance. This role will lead a team of QA professionals driving continuous improvement initiatives managing complex quality issues and acting as a key interface with regulatory bodies and external partners. The Senior Manager will ensure that all pharmaceutical manufacturing testing and distribution activities adhere to Good Manufacturing Practices (GMP) Health Canada regulations and other applicable corporate standards.

Essential Duties and Responsibilities:

• QMS Leadership & Oversight:

• • Provide strategic leadership and oversight for the ongoing development implementation and maintenance of a robust and effective Quality Management System (QMS) in accordance with Health Canada and other applicable regulatory requirements.

  • Drive continuous improvement initiatives within the QMS identifying and implementing best practices to optimize efficiency and effectiveness.

  • Ensure all QMS documentation (SOPs policies work instructions) is current compliant and effectively communicated across the organization.

• Regulatory Compliance & Inspection Readiness:

• • Serve as a primary contact and subject matter expert during regulatory inspections (e.g. Health Canada).

  • Ensure timely and effective resolution of audit observations and regulatory findings including the development and execution of robust CAPA plans.

  • Maintain up-to-date knowledge of pharmaceutical regulations and industry standards assessing their impact and ensuring proactive compliance.

• Batch Review & Disposition:

• • Oversee and manage the timely review and release of finished pharmaceutical products ensuring all batch records analytical data and documentation meet specified quality standards and regulatory requirements.

  • Provide final approval for product disposition (release quarantine rejection)

• Deviation Product Complaints CAPA & Change Control Management:

• • Lead the investigation and resolution of critical deviations non-conformances and out-of-specification (OOS) results product complaints ensuring thorough root cause analysis and effective corrective and preventive actions (CAPA).

  • Manage the change control process to ensure all proposed changes to processes equipment materials or documentation are properly evaluated approved and implemented without compromising product quality or regulatory compliance.

• Auditing Program Management:

• • Develop implement and manage the internal and external audit programs (e.g. supplier/vendor audits contract manufacturer audits).

  • Ensure audit findings are addressed promptly and effectively monitoring the closure of associated CAPA.

• Quality Agreements:

• • Participate in the negotiation and maintenance of Quality Agreements with contract manufacturing organizations (CMOs) contract testing laboratories and other critical suppliers.

• Quality Risk Management:

• • Champion quality risk management principles integrating risk-based decision-making into all QA activities and QMS processes.

• Data Integrity:

• • Promote and ensure adherence to data integrity principles throughout all quality-related activities and systems.

• Training:

• • Ensure the development and delivery of effective GMP and QMS training programs for relevant personnel across the organization.

• Team Leadership & Development:

• • Lead mentor and develop a team of Quality Assurance professionals fostering a culture of quality accountability and continuous improvement.

  • Conduct performance reviews set objectives and support professional growth opportunities for team members.

Skills

This position requires an advanced level of initiative and judgment in order to organize and prioritize tasks workload and projects. Courtesy tact and diplomacy are required in dealing with colleagues in every day working relationships.

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 oneonone or group situations or over the telephone.

Communicates well in writing by composing clear documents; facility with editing and/or proof-reading is required.

Able to work with minimal of supervision.

Proficiency in all Microsoft Office applications (especially Excel Word and PowerPoint)

Supervision/Leadership

This position has direct reports. Leader provides coaching and support to team and other peer and management team members.

Education

• Requires a university degree in sciences; pharmacy chemistry microbiology biology or similar recognized as equivalent to Canadian science degree.

• Quality Assurance and Regulatory Affairs certificate program preferred.

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  Experience

  Minimum of 10 years experience in a quality function in a pharmaceutical manufacturing environment.

  Minimum of 5 years leading and managing a team.

  Minimum of 5 years experience working within a GMP environment.

  Previous experience dealing with Health Canada and / or FDA.

  Previous experience working with a Quality Management System.

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 Youll 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 Canadas diversity as a source of national pride and strength. We have made it a priority to reflect our nations 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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