Director, Quality Assurance

1 week ago


Laval, Canada Bausch Health Full time

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn''t just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.Position title: Director, Quality Unit**1. Purpose of position (mission, objective)**Lead the Quality Unit at Bausch Health Laval, ensuring site-wide compliance with Quality and cGMP standards in collaboration with site leadership.Serve as the Quality Unit Head for Canadian market activities, ensuring all commercialized products meet Health Canada requirements for distribution and commercialization.Provide strategic Quality oversight to the Canadian External Manufacturing QA (EMQA) team, supporting uninterrupted supply of products manufactured through external contract partners.Champion continuous improvement initiatives within the Quality Management System to enhance operational effectiveness, efficiency, and regulatory compliance.**2 Key responsibilities**Deliver strategic leadership across all Quality functions, including Quality Assurance, Quality Systems, and Regulatory Compliance.Oversee the development and execution of robust, end-to-end quality processes that align with applicable regulatory standards.Foster a culture of performance, continuous improvement, and quality excellence, supported by metrics to monitor operational effectiveness.Promote a quality-driven mindset across internal teams and external partners, ensuring collaborative support for business objectives and timelines.Direct daily Quality operations including product disposition, non-conformance handling, OOS investigations, escalations, complaint management, and change control.Manage supplier qualification and external quality oversight.Ensure product quality and disposition for externally manufactured goods.Provide compliance expertise and support for R&D initiatives and product transfers.Act as Importer of Record and Marketing Authorization Holder (MAH) for Canadian-marketed products.Serve as the primary host for regulatory inspections and customer audits.Stay ahead of regulatory changes and ensure proactive compliance across all Quality functions.**3. Management responsibility**Continuously evaluates and develop a fit for purpose Quality organization to meet the business and compliance needsDevelops effective recruitment and talent development processes to ensure Bausch Health attracts and retains top talentProactively engages with the external manufacturing network, developing relationships with joint value creationResponsible for ensuring the Quality Strategy is understood and deployed at the site**4. Resources**Establishes all budgets for the Quality department (operations and investments)Sets annual performance objectives for the Quality departmentOversees the proper application of performance measurement tools and sets prioritiesSupervises and controls department management with respect to budgeting for costs, quality, deadlines and human resources managementDefines the departments organization with a view to ensuring optimization**5. Main professional relationships (internal/external)**Member of the sites leadership team and participates in driving the strategic direction of the siteMember of the Global Quality Leadership TeamLiaising with health authorities, clients, subsidiaries, and management at other sitesPromotes cross-functional discussions to achieve the sites and commercial objectivesPlays an advisory and expert role for other departments on quality issuesInternal:Member of the Site Leadership TeamGlobal Quality LeadershipCross functional leadership (Regulatory Affairs, Research and Development, Supply Chain, Manufacturing, Pharmacovigilance, etc.)External:External suppliers/ service providersExternal ClientsHealth authorities**6. Required skills and competencies:**a) Required trainingBachelor or Masters degree in Chemistry, Pharmacy, or Biological Sciencesb) LanguagesFluent in French and Englishc) Special experience and knowledgeMinimum10 to 15 years of experience in the pharmaceutical industry. Experience essential in quality control, quality assurance, production of pharmaceutical products, medical devices, pharmaceutical development.Excellent knowledge of Canadian and international GMP standards (FDA, EMA, WHO)Minimum 10 years of management experience.We are an Equal Opportunity Employer. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.



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