Associate Director, Global Device Introduction and Maintenance

Associate Director, Global Device Introduction and Maintenance

Ferring Pharmaceuticals

St-Prex, Switzerland

THE TEAM

The Global Device Introduction & Maintenance team is responsible for:

  • Ensuring input on design for manufacture and supply chain to global medical device projects;
  • Leading design transfer/tech transfer in global medical device projects;
  • Maintaining commercial medical devices (design changes, DHF, process…), including managing agreed change projects and investments;
  • Device supplier relation management for selected suppliers (Third Party Manufacturers/CMO’s).

You will be leading a department with significant impact on bringing patient centric solutions efficiently to the market and maintaining them, which is key to Ferring’s commercial success. The department is located in Ferring Headquarters in St. Prex, Switzerland and is part of the Global Device R&D function area in the Global Pharmaceutical Research & Development organization. The portfolio of our medical devices is broad, with the primary focus on drug delivery devices and a large degree of outsourcing is applied.

THE POSITION

Your main responsibilities will be:

  • Lead & manage the department, including:
    • People management;
    • Budgeting and follow-up;
    • Resource management;
    • Stakeholder management.
  • Lead & manage agreed global device maintenance projects, from project initiation to closure (e.g. larger design changes, design/tech transfer to other suppliers, etc.), including:
    • Management of significant external costs and handling of substantial equipment investments;
    • Awareness to identify drug primary packaging/compatibility aspects in connection with changes and ensure that relevant responsible function areas are involved to handle these.
  • Ensure pro-active maintenance of commercial global devices:
    • Managing commercial medical device overview;
    • Managing smaller design changes and support on manufacturing process issues;
    • Ensuring DHF maintenance (including risk management);
    • Supporting complaint investigations & technical questions.
  • Provide input to global device development projects:
    • Ensure timely consideration of supply chain setup/manufacturing strategy in close collaboration with Product Supply and rest of R&D;
    • Design for manufacturing (including robust design and manufacturing processes) in close collaboration with TPM’s/CMO’s.
  • Lead/manage design transfer and tech transfer activities in agreed global device development projects:
    • Partner with R&D, manufacturing sites, third party manufacturers/CRO’s to ensure knowledge is captured and transferred;
    • Take accountability for the technical acceptance of reliable and well understood device manufacturing processes into Product Supply;
    • This includes managing substantial equipment investments and qualification.
  • Maintaining agreed device supplier relations:
    • Actively manage key suppliers in collaboration with rest of supplier management team and maintain contact with lower tier device suppliers with a risk/issue based approach.

QUALIFICATIONS

Professional competencies:

  • Holds a M.Sc. or Ph.D. in a relevant discipline (typically engineering or natural science);
  • At least 10 years experience in medical device development or production, with demonstrated project and people management experience;
  • Strong working knowledge within medical device design control, design changes, manufacturing processes (validation, QC, packinging), CAPA’s, statistical methods;
  • Experience with managing and collaborating effectively with external third party manufacturers/CMO’s;
  • Preferable: experience with drug delivery medical devices, including drug-device combination products, drug CMC interface aspects, and GXP regulated work within the pharmaceutical industry.

Personal competencies:

  • Excellent leadership skills;
  • Strong ability to work effectively across organizational boundaries in a large organization, manage stakeholders, and influence in a collaborative way;
  • Good communication skills, excellent command of English (spoken and written), and preferably French;
  • Ability to work well both as an integral part of larger project teams but also as a self-starter;
  • Effective in, and motivated by, working in a multicultural and interdisciplinary environment.

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© EuroJobsites 2018

EuroJobsites is a UK 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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