Quality Site Senior Director Marcy

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

We are hiring a Quality Site Senior Director for our bioindustrial site located in Marcy L'Etoile. 
 
What will be your responsibilities at bioMérieux ?

In a context of constant evolution of the site and international regulatory requirements related to our products, you implement the Quality Policy for all Quality Assurance and Quality Control activities. You are the quality management representative at the Marcy L’Etoile site, dedicated to the manufacturing of immunoassays and raw materials for internal use and for other bioMérieux manufacturing sites. 

You will directly report to the VP Quality Manufacturing EME, and functionally to the Site Director of Marcy L'Etoile. This is a site management committee position.
 

• Guarantee the regulatory compliance of the site's products and production processes, according to the applicable standards and regulations (QSR / FDA, European Directives/Regulations IVDD/IVDR, ISO 9001/13485 et 17025 /MDSAP), and product specifications,
• Implement and guarantee the evolution of the Site Quality Management System,
• Ensure communication and monitoring of the site's quality objectives in connection with all levels of the organization,
• Represent the voice of Quality in structuring projects for the Site,
• Be recognized as a partner and cross-functional support for the Clinical and Industry business units (customer audits, complaints, new products, etc.),
• Manage the budget of the Quality department
• Lead and develop a team of 5 quality managers, forming a global team of approximately 80 employees. 

     
Who are you ?
 

• Pharmacist / Engineer / Science background, you have a successful experience of at least 10 years in the field of quality management on demanding industrial sites in terms of satisfaction in an international/customer centric environment (Pharmaceutical, Biotechnology, Agri-food industries, Cosmetic).
• You have outstanding knowledge of production processes and process risk management, the Global Quality approach, as well as information systems specific to QA / QC.
• You have proven experience of applicable Regulatory and Quality Standards and hosted extensive Customer, European and international health inspections (ANSM, FDA).
• Your team management skills, your leadership, your pragmatism, your ease in working in the field, as well as strong communication and negotiation skills will succeed in this position. 
• Fluent French/English.

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.