Associate Director Quality - F/M

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 an Associate Director Quality under permanent contract for our Third Party Products Global function.

You manage a team of 7 employees and will be appointed as the Quality Management Representative of Third Party Products.

You will directly report to the VP Quality Manufacturing Europe & TPP, and participate to the TPP Steering Committee.

What will be your responsibilities at bioMérieux ?

• Appointed Quality Management Representative for bioMérieux Third Party Products. Specifically,
  • Execute the bioMérieux Quality Policy
  • Effectively establish and guarantee the evolution of the Quality Management System
  • Report to the bioMérieux TPP Steering Committee the performance of the QMS
  • Ensure promotion and awareness of the Regulatory Requirements throughout the TPP function
  • Ensure communication and monitoring of the quality objectives in connection with all levels of the organization
• Recruit and develop personnel, establish resources and determine actions necessary to accomplish TPP Quality Objectives and provide bench strength for the organization.
• Establish and maintain relationships with required external and internal interfaces to ensure customer and quality requirements are understood and being achieved.
• Communicate technical and financial aspects vertically and horizontally in the function.
• Drive Functional and Operational Excellence within the TPP function.
• Promote the Corporate Quality Audit Program.
• Support and ensure preparedness for external audits.
• Lead and/or facilitate teams to accomplish the deliverables, milestones and objectives meeting the plans and schedules ensuring changes to the plans are communicated and agreed to by the teams and project sponsors.
• Guarantee the regulatory compliance of the products and/or services and processes, according to the applicable standards and regulations (QSR / FDA, European Directives/Regulations IVDD/IVDR, ISO 9001/13485 et 17025 /MDSAP)
• 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
• Manage and develop the team with a view to optimizing the organization

Who are you ?

• Pharmacist / Engineer / Science background, you have a successful experience of at least 5 years in the field of quality management on industrial (Pharmaceutical, Biotechnology, Agri-food industries, Cosmetic).
• You have oustanding 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 in hosting customer and regulatory audits ( 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.

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.