Director, Quality Assurance
Director, Quality Assurance
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Job Description
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 doesnt 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 needs
Develops effective recruitment and talent development processes to ensure Bausch Health attracts and retains top talent
Proactively engages with the external manufacturing network developing relationships with joint value creation
Responsible 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 department
Oversees the proper application of performance measurement tools and sets priorities
Supervises and controls department management with respect to budgeting for costs quality deadlines and human resources management
Defines 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 site
Member of the Global Quality Leadership Team
Liaising with health authorities clients subsidiaries and management at other sites
Promotes cross-functional discussions to achieve the sites and commercial objectives
Plays an advisory and expert role for other departments on quality issues
Internal:
Member of the Site Leadership Team
Global Quality Leadership
Cross functional leadership (Regulatory Affairs Research and Development Supply Chain Manufacturing Pharmacovigilance etc.)
External:
External suppliers/ service providers
External Clients
Health authorities
6. Required skills and competencies:
a) Required training
Bachelor or Masters degree in Chemistry Pharmacy or Biological Sciences
b) Languages
Fluent in French and English
c) Special experience and knowledge
Minimum10 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.
Required Experience:
Director
Employment Type
Full Time
