Associate Director Quality

il y a 4 jours

Lyon, France bioMérieux sa Temps plein

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.

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