Location:
1685 Tech Ave, Mississauga, Ontario, L4W 0A7
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?
Director, Scientific Affairs & Quality Assurance
Reporting directly to the Senior Director, Quality Assurance, the incumbent will be responsible for strategic leadership and functional management of quality assurance, drug safety / pharmacovigilance and compliance governance at Shoppers Drug Mart Specialty Health Network to ensure compliance with established procedures, relevant regulations, client requirements and industry guidelines. The incumbent is a proven leader capable of engaging with key stakeholders across all levels of the organization to implement quality requirements and translate business goals into the strategic quality plan.
Responsibilities:
- Champion the Enterprise Vision, Mission and Values
- As an active member of the Specialty Health Network (SHN) Leadership team, play a key role in the development of business strategy and implementation of the strategic vision for SHN
- Lead the SHN Pharmacovigilence and Quality Assurance teams while liaising with partners
- Establish and oversee the SHN Quality, Safety and Compliance 5-year+ Roadmap
- Identify current and emerging regulatory changes that impact quality and safety governance and evolve responsive strategies
- Lead the evolution of a culture of compliance
- Provide strategic leadership on all PV activities to support Patient Support Programs
- Act as advisor to senior leadership on Safety, Quality and Compliance matters
- Ensure that SDM SHN Quality Systems are implemented and comply with GMP regulations and PSP requirements
- Serve as the site Quality Assurance and Safety liaison with external clients and regulatory agencies
- Provide expertise to develop, implement, and maintain quality standard operating procedures that are compliant with client requirements, aligned with quality standards, current industry trends and best practices.
- Ensure that the PV vision and strategy is properly executed and aligned to the client's PV program
- Provide oversight to SHN privacy and medication incident management compliance, working closely with enterprise leaders in the Privacy Office, Enterprise Pharmacy Continuous Improvement and Pharmacy Professional Affairs
- Ensure inspection-readiness at all times; provide expertise to support regulatory or customer inspections in all areas of business across the designated business units.
- Establish effective collaborative relationships with all stakeholders
- Promote activities to foster quality and safety compliance awareness across the organization
- Drive alignment and commitment at all levels of the organization to promote compliance
- Develop, execute, and implement Pharmacovigilance and Quality Agreements, including reviewing of MSA and SOWs
- Support the acquisition of new business/RFPs
- Provide guidance and support to define, track and report on department Key Performance Indicators
- Drive solutions for risk mitigation in collaboration with Management, and stakeholders across the organization
- Lead the development and implementation of internal CAPA plans related to PV and Quality activities or oversee the development, implementation and execution of any necessary CAPA plans
- Provide pharmacovigilance oversight of Patient Support programs and any other initiatives which may generate AE information
- Maintain accountability for quality of data generated, and PV activities performed by PV personnel
- Conduct oversight meetings with Patient Support program teams, maintaining effective business relationships and tracking performance metrics
- Maintain compliance and metric reports regarding core Quality functions (recall, quarantine, inbound hold, release requirements, sampling, return disposition, record retention, training, environmental temperature control, pest control, sanitation, preventive maintenance, vendor qualification, etc.)
- Develop pro-active strategies as preventive measures against potential future issues with systems or processes
- Deliver effective communications, both verbal and written
- Lead, manage and develop the SHN Quality, Safety and Compliance team
- Establish and manage to short and long term departmental objectives, policies, operating procedures, and annual budgets
- Foster high colleague engagement and a ground-up culture of accountability, collaboration and continuous improvement
Skills, Experience, & Education
- University degree in sciences (or Canadian Equivalent)
- Deep pharmaceutical expertise in Canada
- Supply Chain experience an asset
- PSP experience an asset
- Minimum 10+ years experience leading quality assurance in the GMP Pharmaceutical Industry
- Proficient understanding of Medical Device Regulations (e.g. SOR 98/282)
- Proficient understanding of Drug regulations (e.g. GUI-0001, GUI-0069)
- Knowledge of Canadian regulatory regimes related to drug handling and pharmacovigilance
- Established relationships with regulatory bodies (e.g., Health Canada)
- Supply Chain and Logistics experience an asset
- Knowledge of retail or specialty pharmacy an asset
- Experience working in large, matrix organizations and making timely and effective decisions in a rapidly evolving market
- Strong negotiation, influencing and problem-solving skills
- Leadership presence, with confidence to engage and influence internal and external stakeholders
- Strong team leadership and ability to build and maintain effective cross-functional relationships
- Excellent communication across all levels of respective teams and across the enterprise
- Ability to coach and mentor others
- Adaptable to set and prioritize work with varying exceptions. Able to work with diverse personalities and styles.
- Self-motivated and resilient, with a positive attitude and high energy level
- Flexibility to travel (<10%)
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.
Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.
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