Director Medical

6 days ago
Montréal QC, Montreal Regional Municipality, QC; Montréal region; Québec Province, Canada Confidential Full-time
The Director Quality Services is responsible for overseeing both internal and external quality operations and systems. This includes audits, complaints, training, product release, change control, deviations, and overall compliance. The role ensures alignment with current Good Manufacturing Practices (GMPs) and regulatory requirements. Ensure the company maintains valid Establishment Licenses for pharmaceuticals, medical devices, controlled substances, and narcotics. Act as liaison for inspections and conduct supplier audits. Develop and implement a comprehensive quality system across the organization, including GMP-ISO training and updates to procedures. Lead and manage quality audit processes. Drive the development, harmonization, and continuous improvement of quality systems and procedures to ensure compliance with cGxP standards. Identify and assess current and potential quality risks. Manage controlled documents (e.g., SOPs) and ensure regulatory compliance. Oversee documentation related to change requests, deviations, CAPAs, complaints, investigations, and Annual Product Quality Reviews (APQR). Manage stability protocols and reports. Lead the quality team during technical transfers. Oversee the recall process and provide senior-level compliance analysis. Manage the Quality Services department, including staffing, budgeting, development and skill growth. Liaise with third-party manufacturers, Health Canada, and other regulatory authorities. Provide quality assessments and due diligence support for Business Development initiatives. Continuously seek opportunities to improve processes, outcomes, and team performance. Bilingualism (French and English) Ability to manage multiple priorities in a fast-paced environment Master’s degree in a scientific discipline Minimum of 10 years of experience in Quality roles within the pharmaceutical or biopharmaceutical industry Advanced technical and quality expertise in pharmaceuticals Full-time Quality Assurance and Management Pharmaceutical Manufacturing #

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