Director Quality

🚀 Exciting Leadership Opportunity in Quality & Patient Safety Are you ready to lead with purpose and shape the future of quality and pharmacovigilance in a growing, mission-driven organization? We’re searching for an exceptional leader who’s passionate about driving excellence, elevating compliance, and ensuring patients remain at the heart of everything our client does. The Director, Quality & Pharmacovigilance reports directly into the CEO and oversees the delivery of quality assurance and pharmacovigilance services for day-to-day operations (i.e. GMP Operations, Pharmacovigilance, Patient Support Programs, Nursing and Clinics, and Pharmacies). This role is responsible for designing, planning, implementing, directing and evaluating quality assurance and pharmacovigilance functions, and the quality management system as a whole, for product and service delivery across the client company. The Director, Quality & Pharmacovigilance is also responsible for establishing and maintaining a culture of continual improvement, and for promoting collaboration across all business units. This individual will work collaboratively with Senior Leadership, Directors and Managers in the evaluation of product quality assurance and business operations and will identify, recommend and implement necessary changes. PRIMARY DUTIES AND RESPONSIBILITIES: Develop, implement and maintain a Quality Management System (QMS) that ensures ongoing compliance with external regulations, internal company quality standards, and customer requirements. Develop and maintain the Pharmacovigilance function to ensure ongoing compliance with external regulations, internal company quality standards, and customer requirements as they apply to the reporting of Safety incidents and data. Formulate and administer policies and standard operating procedures (SOPs) relating to the quality assurance and pharmacovigilance functions that will ensure compliance, foster a culture of continual improvement, and encourage innovation. Define, develop and implement both short- and long-term strategies, goals, objectives and tactics relating to the quality assurance and pharmacovigilance functions. Ensure that all functions that interact with the QMS (i.e., Warehousing & Importation, Pharmacovigilance, Patient Support Programs, Nursing and Clinics, and Pharmacies) are operating in conformance with all applicable quality standards and regulations. Ensure that Adverse Events and other reportable events are reported in accordance with both regulatory requirements and contractual obligations. Use quality event investigations (e.g. deviations), incidents, corrective and preventive action (CAPA) investigations, and their associated processes, to drive quality improvements and respond to process and service issues. Develop and implement an effective training program for internal departments and functions that have quality assurance and pharmacovigilance responsibilities. Implement an internal quality auditing program covering all quality and pharmacovigilance related activities (including applicable vendors and subcontractors). Ensure all applicable programs, systems, and facilities are ’inspection ready’ at all times. Develop and propose key quality, compliance and performance indicators. Analyze the performance of quality assurance and pharmacovigilance functions, document resolutions, identify problem areas, and devise / deliver solutions to enhance quality control and prevent recurrence. Keep the Senior Leadership team appraised of all quality assurance and pharmacovigilance issues as appropriate. Direct and manage departmental budgets and goals for the quality assurance and pharmacovigilance functions. Manage government interactions requiring governmental approvals, including liaison with the Health Canada and other regulatory agencies as appropriate. What You Bring Bachelor’s or Master’s degree in a Life Science discipline. 10+ years’ experience in healthcare, pharma, or regulated industries, leading quality and/or pharmacovigilance functions. Experience leading Quality Functions across multiple disciplines (i.e., GMP operations, Patient Support Programs, Distribution). Proven expertise in QMS, CAPA, GxP audits, and Health Canada compliance. Strategic mindset with hands-on execution capability. Strong communicator with exceptional emotional intelligence. Bilingualism (French/English) is an asset