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Quality Assurance Director
Il y a 2 mois
About the Role:
We are seeking a highly experienced and strategic Director of Quality to lead the quality operations at our sterile manufacturing site. As the Director of Quality, you will oversee a team of approximately 50 professionals and ensure compliance with all relevant regulations, standards, and guidelines to maintain the highest quality of sterile products.
Key Responsibilities:
- Provide strategic direction and leadership to the Quality Department, ensuring alignment with company objectives and industry best practices.
- Ensure all products meet safety, quality, and efficacy standards.
- Manage and mentor a team of approximately 50 quality professionals, including Quality Assurance (QA), Quality Control (QC), and Quality Systems teams.
- Drive a culture of continuous improvement by implementing best practices, identifying process improvements, and managing quality risk assessments.
- Collaborate with Manufacturing, R&D, Supply Chain, and other departments to ensure quality is integrated into all aspects of production and product development.
- Develop and execute a strategic quality plan that supports the overall business strategy, focusing on growth, efficiency, and sustainability of sterile manufacturing operations.
- Set performance goals, conduct regular reviews, and implement training programs to ensure the team remains highly skilled and motivated.
- Lead investigations into product quality issues, non-conformances, and deviations, ensuring effective root cause analysis and corrective and preventive actions (CAPAs).
- Serve as the primary point of contact for quality-related matters with internal and external stakeholders, including customers, regulatory authorities, and suppliers.
Requirements:
- Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline; a Master's or Doctorate is preferred.
- Minimum of 10 years of experience in quality management within a sterile pharmaceutical or biopharmaceutical manufacturing environment.
- Proven track record in a senior leadership role, managing large teams and implementing strategic initiatives.
- Fluent in English and French (preferred).
- Ability to drive a culture of quality and continuous improvement across the organization.
What We Offer:
- Competitive salary and performance-based bonuses.
- Relocation assistance for the right candidate.
- Opportunities for professional development and career progression.