Quality Site Manager
bioMérieux
Madrid, Spain
What will be your responsibilities at 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
Who are you?
- 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
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