Director, Quality Assurance

Director, Quality Assurance

**Job Location**:Laval, Quebec, CAN

**Job Requisition ID**:14127

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 it—where 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
- 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.

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.