Manager, Quality Assurance

Shoppers Drug Mart - Toronto, ON (il y a 30+ jours)

Postuler dès maintenant

Location:
243 Consumers Road, Toronto, Ontario, M2J 4W8

Take ownership and find more ways to care about our local store owners in a career at Shoppers Drug Mart Central Office / Store Support. Provide great service, specific expertise and actionable advice to support Associate-Owners and their staff in delivering the best health, beauty and convenience services to Canadians.

Why this role is important?

Reporting directly to Sr. Manager, Quality Assurance, the incumbent will be responsible for quality and regulatory management oversight of Loblaw and SDM front shop Health Products (OTC Drugs, Medical Devices, and Natural Health Products), eCommerce and computerized systems validation in compliance with Canadian laws and Health Canada regulations and guidelines.

What You'll Do:
Working closely with Operations, Information Technology (IT) and external suppliers, the Manager, Quality Assurance will provide leadership in establishing and maintaining the quality systems and standards specific to front shop and eCommerce Health Products classified as drugs, natural health products and medical devices and validation of computerized systems with quality/regulatory impact.

Change Control (Internal and External)

Manage the change control processes for:
Front Shop article create/listing/de-listing/changes to existing articles in the master database
Goods Not For Retail (GNFR) article create/changes
Monitoring MicroStrategy Listing Reports

Work closely with the following teams:
Loblaw Central Data Management (CDM) to ensure data integrity
Merchandizing Category to ensure timely regulatory review of front shop articles
EPG (Enterprise Procurement Group) to ensure timely regulatory review of GNFR articles
Customs Compliance to support the business requirements and ensure compliance to regulatory requirements for the importation of Health Products
Reclassification of article categories/fine lines in the master database
Assigns/Verifies front shop Pharmacy Schedules in accordance with the National Drug Schedules and each Provincial Drug Schedules Regulation
Process/Equipment/Computerized Systems/Supplier/Material with quality and regulatory impact
Manage the QA processes to maintain the regulatory fields in the master database (SAP) for front shop articles
Review and perform quality/regulatory impact assessment of changes to validated computerized system
Manage timely completion and closure of change requests
Internal/External Quality/Regulatory Audits
Manage the audit program for Front Shop Distribution Centers/Warehouses
Audit related Front Shop service suppliers
Oversight and support to maintain site precursor licenses
Auditing of the Loblaw and SDM eCommerce sites e.g. SDM.ca, PCX
Manage timely completion of corrective/preventive actions and closure of audit records
Support Precursor/Other Regulatory (e.g. Health Canada) inspections with the Sr. Manager QA and Sr. Director QA
Management of the eCommerce Quality Assurance
With assigned direct report/s, oversee the Quality Assurance activities for eCommerce
Ensure any vendor (manufacturer/importer/distributor) marketing and advertising material is approved by Health Canada prior to appearing on e-commerce websites
Oversee regular audits of the online platform products to ensure regulatory compliance with National Pharmacy Regulations and Standards in the respective provinces and federal regulation requirements
Provide oversight ensuring only quality assurance approved products are listed to the eCommerce platforms
Supplier Quality Management
Incumbent will be responsible for qualifying Front Shop vendors, distribution sites, transport providers and ensuring establishment of Quality Agreements, as required
Support negotiation of legal Quality Agreements with suppliers for approval by the Sr. Manager QA and Sr. Director QA

Computerized System Validation/Qualification:
Write and execute Validation Master Plan and validation protocols
Review and approve validation protocols and reports
Follow-up on completion of validation/re-validation

Non-conformances/Deviations/CAPAs:
Provide oversight of Product Hold/Quarantine/Reject process for Front Shop Health Products
Manage the communication with the suppliers in obtaining product stability information or requesting product stability assessment
Provide product disposition to distribution center QA in the event of product impacting temperature excursion
Ensure that Non-conformances/Deviations/CAPAs are initiated, investigated and closed on time

Document/Record Management:
Review government, regulatory and corporate policies to ensure all procedures are current and meet requirements for front shop health products
Identify compliance gaps, develop and timely implement plans to address compliance gaps
Manage document and record compliance for Front Shop products at the Distribution Centers
Create/Revise SOPs for implementation at the Distribution Centers
Returned Products
Manage the QA processing for Front Shop products returned products and associated documentations and provision of product disposition
Personnel Training
Conduct personnel training on GMPs and SOPs
Track timely completion of personnel training and manage personnel quality training records
Management Review Meetings
Report on the status of Front Shop and eCommerce distribution center Quality Systems to Sr. Manager, QA
Present and participate in the quality management review meetings
Prepare quarterly and annual reports on quality metrics
Provide leadership to direct report/s

Others:
Support of other Healthcare businesses, as required
Perform other Quality duties, as assigned
Occasional travel to various distribution centers and vendor sites, as required

What You'll Need:
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 direct report/s and colleagues in every day working relationships.

Minimum 7 years working in the GMP pharmaceutical industry in Quality Assurance
Must have a Bachelor of Science degree (or Canadian Equivalent)
Must have a strong validation experience - writing, execution and reporting
Strong understanding and sound interpretation of Health Canada GMP and other related guidelines, Medical Device Regulations, Natural Health Product Regulations, the Narcotic Controlled Regulations, Controlled Drugs and Substances Act, Benzodiazepine and Other Targeted Substances Regulations, Precursor Control Regulations, Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances)
Strong Quality and risk-based approach decision making and business acumen
Quality Auditor Certification and audit experience an asset
Regulatory Affairs, Supply Chain and Logistics experience, an asset

Additional Skills and Experience:
Requires an ability to apply concepts and theories to improve functions or units.
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 and critical 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 and supply chain/logistics environment
Ability to handle sensitive issues requiring timely completion of documentation in order to control deficiencies and expedite product dispositions
Sound knowledge of compliance and regulatory components, auditing skills, and quality systems
Interpret Health Canada GMPs and other Guidelines and regulations, PIC/s, corporate policies/standards to determine SDM position regarding quality processes, compliance requirements
Maintaining quality and patient safety first while recognizing the importance of good business decisions
Computer skills to produce effective reports, documents, spreadsheets and presentations.
Communicates with clarity, verbally to conduct personnel training and in one on one or group situations, or over the telephone.
Communicates well in writing by composing clear documents
Able to work with minimal of supervision.
Proficiency in all Microsoft Office applications (especially Excel, Word and PowerPoint)

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 SDMU.

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.