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 department’s organization with a view to ensuring optimization

5. Main professional relationships (internal/external)

· Member of the site’s 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 site’s 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 Master’s 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.