Quality Site Manager

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bioMérieux

Site Leader for regulatory and customer enquiries regarding Site Quality Systems.
Guarantees 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 and 17025 /MDSAP), and recommend corrective/improvement actions where needed.
Maintain and guarantee compliance and the evolution of the Site Quality Management System,
Leads or facilitates teams to accomplish deliverables, milestones and 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.),
Understand how to Manage budget process.
Manage and develop the team with a view to optimizing the organization

Pharmacist/Life Science background with Microbiology knowledge, 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). Experience in culture media will be a plus.
You have outstanding knowledge of production processes and process risk management, the Global Quality approach, as well as information systems specific to QA / QC.
Knowledge in the interpretation and application of relevant domestic and international regulations and Industry standards (ISO 9001 & ISO 13485 required and ISO 17025 preferred ….)
You have proven experience of applicable Regulatory and Quality Standards and hosted extensive Customer, European and international health inspections: ANSM, FDA, etc...
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 Spanish/English. French will be a plus

Don't forget to mention EuroPharmaJobs when applying.

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