Senior QMS IT System Manager

3 days ago


Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Radiometer Danmark, a subsidiary of Danaher, is a leading manufacturer of diagnostic equipment. We are seeking a highly skilled Senior QMS IT System Manager to lead the implementation and management of our Quality Management System (QMS) IT system.

Job Summary

The successful candidate will have extensive experience in managing QMS IT systems, particularly in the pharmaceutical or medical device industry. They will be responsible for overseeing the replacement of our current on-premise MasterControl system with a new QMS IT system before the end of 2025. This role will also involve managing the support and potential changes to the current system.

Key Responsibilities
  • Lead the technical project team in implementing and migrating to the new QMS IT system.
  • Manage third-party vendors, including the QMS IT system supplier and implementation partner.
  • Oversee the expansion of the future QMS IT system to include relevant areas and functionalities, such as CAPA process, non-conformance process, audit management, and potentially complaint management.
  • Develop and implement roadmaps for IT QMS systems and drive cross-departmental implementation through stakeholder management.
Requirements

To excel in this role, the ideal candidate should possess:

  • A relevant higher educational degree.
  • Proven track record in project management, implementing IT solutions from requirement to deployment.
  • Experience with management of QMS IT Systems (+5 years).
  • Experience managing GxP validated systems according to FDA 21 CFR Part 820 Quality System regulation.
  • Strong leadership skills, with the ability to motivate and lead technical professionals and experts.
  • Excellent communication skills and fluency in English.
Salary and Benefits

We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience, plus additional benefits, including a comprehensive health insurance package, retirement plan, and opportunities for professional growth and development.



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