Director of Quality Management
il y a 2 semaines
We are seeking a highly experienced and strategic Director of Quality to lead the quality operations at our sterile manufacturing site located in the South of France. This role requires a dynamic and fast-paced leader who is a Qualified Person (QP) under EU regulations.
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:- Quality Leadership: Provide strategic direction and leadership to the Quality Department, ensuring alignment with company objectives and industry best practices.
- Qualified Person Responsibilities: Act as the Qualified Person (QP) for the site, overseeing product release in compliance with EU GMP requirements. Ensure all products meet safety, quality, and efficacy standards.
- Operational Oversight: Manage and mentor a team of approximately 50 quality professionals, including Quality Assurance (QA), Quality Control (QC), and Quality Systems teams.
- Regulatory Compliance: Ensure site compliance with all relevant regulatory requirements, including EU GMP, ISO standards, and local regulations. Lead preparations for regulatory inspections and audits, including responses and follow-up actions.
- Continuous Improvement: Drive a culture of continuous improvement by implementing best practices, identifying process improvements, and managing quality risk assessments.
- Cross-Functional Collaboration: Collaborate with Manufacturing, R&D, Supply Chain, and other departments to ensure quality is integrated into all aspects of production and product development.
- Strategic Planning: Develop and execute a strategic quality plan that supports the overall business strategy, focusing on growth, efficiency, and sustainability of sterile manufacturing operations.
- Performance Management: Set performance goals, conduct regular reviews, and implement training programs to ensure the team remains highly skilled and motivated.
- Problem Solving: Lead investigations into product quality issues, non-conformances, and deviations, ensuring effective root cause analysis and corrective and preventive actions (CAPAs).
- Stakeholder Management: Serve as the primary point of contact for quality-related matters with internal and external stakeholders, including customers, regulatory authorities, and suppliers.
- Qualified Person (QP) under EU GMP 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.
- In-depth knowledge of sterile manufacturing processes, EU GMP, ISO standards, and other relevant regulatory frameworks.
- Strong experience in handling regulatory inspections and audits.
- Excellent communication, leadership, and interpersonal skills.
- Fluent in English and French (preferred).
- Competitive salary and performance-based bonuses.
- Relocation assistance for the right candidate.
- A dynamic and challenging work environment.
- Opportunities for professional development and career progression.
- The chance to live and work in the beautiful South of France.
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Director of Quality Management
il y a 2 semaines
Lourdes, Occitanie, France Barrington James Temps pleinDirector of Quality ManagementBarrington James is seeking a highly experienced and strategic Director of Quality to lead the quality operations at our sterile manufacturing site in the South of France.Key Responsibilities:Provide strategic direction and leadership to the Quality Department, ensuring alignment with company objectives and industry best...
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Director of Quality Management
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Lourdes, Occitanie, France Barrington James Temps pleinJob Title:Director of Quality ManagementJob Summary:Barrington James is seeking a highly experienced and strategic Director of Quality to lead the quality operations at our sterile manufacturing site located in the South of France.Key Responsibilities:Provide strategic direction and leadership to the Quality Department, ensuring alignment with company...
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Director of Quality Management
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Lourdes, Occitanie, France Barrington James Temps pleinJob Title: Director of QualityLocation: South of FranceAbout the Role:We are seeking a highly experienced and strategic Director of Quality to lead the quality operations at our sterile manufacturing site located in the South of France. This role requires a dynamic and fast-paced leader who is a Qualified Person (QP) under EU regulations. As the Director of...
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Director of Quality Management
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Lourdes, Occitanie, France Barrington James Temps pleinJob Title: Director of QualityLocation: South of FranceAbout the Role:We are seeking a highly experienced and strategic Director of Quality to lead the quality operations at our sterile manufacturing site located in the South of France. This role requires a dynamic and fast-paced leader who is a Qualified Person (QP) under EU regulations. As the Director of...
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