Director, Head of Quality (f/m)

at a start-up company with a breakthrough technology in tumor surgery
Standort Land Branche Referenz
Groningen or Munich International Life Sciences / Pharma FK1289
Our client is a start-up company headquartered in Groningen, the Netherlands with offices in Munich, Germany who developed a patented, breakthrough technology for fluorescence image-guided surgery, enabling surgeons to detect tumor tissue more accurately and thus improve outcome. The technology platform consists of an injectable imaging agent and a highly sensitive detection device. Being an independent part of an international market leader in diagnostic imaging, the company offers the advantage of working in a start-up atmosphere combined with the financial backing of an international corporation.

The Director, Head of Quality (f/m) will be responsible for leading and managing Quality Management System in accordance with corporate and regulatory requirements.

The position can either be located in Groningen, the Netherlands or Munich, Germany.

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Ihre Aufgaben

  • Primary decision maker responsible for overseeing and providing compliance direction to all functions of the company
  • Primary Quality contact for interactions with all contract manufacturers, sister companies, Corporate Quality Management (CQM), as well as all internal departments within the company
  • Generating Chairs Management Reviews to ensure Management involvement and visibility to quality issues
  • Developing and implementing the adequate (GXP and ISO) Quality System with processes and tools to manage in compliance the company operations
  • Assure and maintain adequate ISO Certification program
  • Ensuring all quality systems of the company divisions according to the international guidelines and requirements
  • The primary quality approver on Design History Documents, Product Specifications, Labeling Materials, Product Registrations, deviations, complaints, CAPAs, Protocols, Reports, Supplier Approvals
  • Quality Leader of the product development teams
  • Lead of quality aspects of projects that impact cross functional departments
  • Lead and performing of quality audits (internal and external) for medical devices and pharma products
  • Ensuring regular reporting to the Management and Corporate Quality Management
  • Oversees the monitoring and implementation of applicable regulations and standards as they evolve

Ihr Profil

  • B.S. in Science, Engineering or equivalent combination of education and experience
  • At least 10 years of experience in Medical Device and Pharma manufacturing environment
  • Medical device / Pharma Quality System auditing skills, certification preferred
  • At least 15 years of QA related experiences
  • Drug GMP and Medical Device experiences are a must
  • Quality related expertise in FDA and CE certification processes
  • Drug GCP knowledge is a strong plus
  • Proven track record in quality project management is a plus
  • Fluent in English, additional languages are an asset

Ihre Chance

  • High level responsibility in an exciting and dynamic environment
  • Fascinating challenge in high-end medicine
  • Be part of the introduction of a breakthrough technology for tumor surgery
  • Be a major part of a small team in an exciting industry
  • Work in a start-up atmosphere with the background of an international market leader
  • Possibility to benefit from car allowance
  • Additional benefits as insurances and pension fund

Haben wir Ihr Interesse geweckt? Dann freuen wir uns, Sie kennen zu lernen!

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Gerne beantworten wir Ihre Fragen rund um die Stelle und zur Bewerbung:

Bild Fritz Kurz

Fritz Kurz

Managing Partner

T +49 89 203 00 62 97
F +49 89 203 00 62 96

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Siegfried Faix

Managing Partner

T +49 761 888 51 23 10
F +49 761 888 51 23 99