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Director of Quality
Il y a 2 mois
Job Title: Director of Quality (Qualified Person) – Sterile Manufacturing Site
Location: South of France
About 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 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.
Qualifications:
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).
Key Attributes:
Strategic thinker with a hands-on approach to problem-solving.
Ability to thrive in a fast-paced and dynamic environment.
Strong organizational and decision-making skills.
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.
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.
