Manager, Quality Assurance

at  Specialty Health Network Inc

Referred applicants must not apply directly to this role. All referred applicants must use their unique referral link generated when they are referred by an existing colleague.

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.

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 on-going 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 covers quality goals with main emphasis on Key Performance Indicators (KPI’s) applicable to quality system elements.

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.