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Location: Grenoble, France
Position Type: Unfixed Term
Job Function: Quality
A family-owned company, bioMérieux 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 family-owned global company with a long-term vision, and a human-centered culture.
We are hiring a Quality Site Director W/M for 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 bioMérieux ?
Guarantee the evolution of the Site Quality Management System taking into account regulatory and customer enquiries
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,
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 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
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, 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.
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.