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You will be updated with latest job alerts via emailA familyowned company bioMrieux has grown to become a world leader in the field of in vitro diagnostics. For almost 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 familyowned global company with a longterm vision and a humancentered culture.
We are hiring aQuality Site Director W/Mfor our manufacturing and R&D sites located in Grenoble and Verniolle acting in the molecular biology sector which is strategic and In expansion phase.
In a context of site growth and regulatory requirements related to our products you implement the Quality Policy for all Quality Assurance and Quality Control activities. You manage a team of around 38 employees and will be appointed as the Quality Management Representative of Grenoble and Verniolle sites.
You will directly report to the VP Quality Manufacturing and functionally to the Site Director of Grenoble and Verniolle. This is a site management committee position.
What will be your responsibilities at bioMrieux
Guarantee the evolution of the Site Quality Management System taking into account regulatory and customer enquiries
Guarantee the regulatory compliance of the sites 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
Manage and develop the team with a view to optimizing the organization establishes resources and determines actions necessary to accomplish Site Quality objectives.
Ensure communication and monitoring of the sites 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 crossfunctional support for the Clinical and Industry business units (customer audits complaints new products etc.
Manage the budget of the Quality department
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 Agrifood 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 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 French/English.
bioMrieux 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.
Required Experience:
Director
Full Time