Head of Quality & Regulatory Affairs for Industrial Microbiology

Head of Quality & Regulatory Affairs for Industrial Microbiology

bioMérieux

Craponne, France

We are looking for a Head of Quality & Regulatory Affairs who will work and grow within the Industry Unit and will report to the Executive VP Industrial Microbiology and in dotted line to the Executive VP Quality, Manufacturing & Supply chain. You will manage 2 direct reports and coordinate a quality community. This position will require you to serve as a member of the Quality Board and represent Quality in the Executive Committee for the Industrial Microbiology Business Unit.

What will be your mission?

  • Ensure an efficient Quality Management System is established in the Industrial Microbiology Business Unit in compliance with Corporate and External requirements (applicable standards, regulations and customers’ requirements);
  • Contribute to building strong customer relationships: make Quality part of the customer sales offer including identifying customer needs and being proactive in order to meet their expectations, particularly for pharma customers;
  • Manage interfaces with key contributors in the Industrial Microbiology Business Unit (manufacturing sites, Supply Chain, subsidiaries …) in order to obtain customer satisfaction;
  • In charge of infusing Quality culture within the business unit: ensure the implementation of corporate Quality policy and objectives, establish and implement appropriate Quality training for the Unit team;
  • Establish, implement and maintain up-to-date processes in compliance with associated regulations, standards and customer requirements, including setting up a standard watch in collaboration with Scientific Affairs;
  • Act as the Quality Management Representative for the Industrial Microbiology Business Unit : Define an effective Quality organization in the Unit, establish resources and determine actions necessary to accomplish objectives;
  • Coordinate Management reviews with key departments based on process reviews: R&D, Marketing, Complaint Handling Process, Vigilance and customer quality agreement management;
  • Report on QMS performance by defining relevant Quality KPIs and define needs for improvement;
  • Manage the defined Quality improvement plan and facilitate teams to accomplish the deliverables, milestones and objectives in order to meet the plan.

Who are you?

Knowledge and skills:

  • Pharmacist/Biologist/Engineer with a high level of scientific background;
  • Quality Manager with at least 10 years of Industry experience in a health-related field;
  • Strong knowledge of Standards and Regulations of medical devices and/or pharmaceutical activities.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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