Manager, Quality Services

Reporting to the Director of Quality Services, the Manager is responsible for providing oversight and manages compliance for the quality systems under their scope. This includes responsibility for deviations, CAPAs, change controls and product release.  This role ensures regulatory compliance for all drug products, NHPs and medical devices and systems.  The Manager acts as lead Quality on assigned projects to provide continuous improvement of systems and products. They assure compliance with current Canadian and international GMPs and other regulatory standards.

Job Description

• Lead operational team in the development, management, harmonization, and improvement of quality systems and procedures.
• Make decisions on all aspects of quality systems under their scope, such as Change Control, Deviations, Investigations, Release and CAPA systems to assure compliance and timely and accurate completion of reported events.
• Continuous improvement project lead.
• Document and monitor KPIs under their scope.
• Lead the QA batch release and distribution activities from the contract manufacturing, testing and packaging facilities, including non MRA requirements.
• Lead the review and/or approve change controls received from suppliers or initiated internally and ensure timely closure.
• Review, assess and approve internal or external deviations/investigations before product release. 
• Prepare and/or review controlled documents (e.g. SOP's) required for compliance.
• Manage and coordinate QA staff and/or consultants towards the timely completion of assigned duties and responsibilities.

Your Profile

• Bachelor's degree in administration or in science. 
• 8+ years of experience working in a Quality role in a GXP environment in the pharmaceutical or medical device industry.
• 2+ years' experience in production and people management. 
• Considered an expert in QA disciplines and expert understanding and knowledge of cGMP/ISO 13485 regulations.
• Thorough understanding and experience in Root cause analysis, product release and change controls.
• Ability to effectively lead teams in problem solving and continuous improvement.
• Bilingual (French and English) with excellent oral and written communication skills.