Job Details
Job ID: 130
Job Title: Site Director Quality
Job Type:
Hire Type: Direct Hire
Level: Managerial
Recruiters: Hannah Woodward
City: Rueil
Country France

Job Description
Description: For our manufacturing location at Dreux, France, we are currently recruiting a Site Quality Director. In this role you will report to the Senior Director Manufacturing and Operations Quality. You will also provide leadership to ensure the site and product manufactured at the site are of suitable quality and are in compliance with regulatory expectations. You will lead a team of 30 people within QA, QC, Validation and Engineering Compliance.
Requirements/Qualifications: • A Pharmacist degree is obligatory
• Eligible to act as a Qualified Person under Directive 2001/83/EC
• Sound understanding and application of all CGMP, GOP and IS013485 in the manufacture and supply of medicinal products and medical devices.
• Sound grasp of budget, financial and operational controls with a proven record of building and delivering challenging budgets
• Excellent verbal and written communication skills and the ability to present to all levels Ability to collaborate, negotiate, influence and agree outcomes with all levels of the business

An extensive profile is available, please reach out to Helen Cioni for more information at +31 6 15 26 55 56
Responsibilities: • Responsible for management of the site Quality Function deploying resource to implement the Norgine Quality Management System, policies and procedures across the Dreux site.
• Ensuring the site is continuously at a level of compliance with the expectations of the supervising Competent Authority and all regulatory inspection agents, assuring inspection readiness.
• Ensuring all products are manufactured in compliance with regulatory filings and in accordance with GMP.
• To provide leadership and guidance to site Quality staff to ensure continued team and individual development, motivation and performance improvement.
• Responsible for ensuring global policies and procedures are translated and implemented into robust local processes and procedures. Feeding back to approving authorities inconsistent and or misaligned requirements.
• Within the context of management guidelines, commercial requirements and manufacturing plans construct, gain agreement of and manage the department budget.
• Key member of the Global Quality team, developing and maintaining Norgine Quality Strategy and Key Performance Indicators.
• Ensuring that Dreux operational quality needs and objectives are represented Provide support to and gain support from Regulatory, Medical, Commercial Busines Units and R&D.
• Acting in a capacity on behalf of Norgine Ltd., and to act generally on behalf of all Norgine legal entities including without limitation, inspections/audits etc.
• Agree and manage the Quality Department budget.

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