Senior Director, Quality Assurance & Regulatory Affairs
- Toronto, ON
- Permanent
- Temps-plein
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?Reporting directly to the Vice President, Pharmaceutical Sourcing and Commercial Operations, the incumbent will be responsible for Management oversight of Quality and Regulatory activities.Duties: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
- Shoppers Drug Mart
- Medisystem Pharmacy
- Central Pharmacy Services
- Sanis Inc.
- Specialty Health Network
- 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 on one 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)