IT QMS Senior Project Manager

2 weeks ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

In our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating impactful innovations like ours, doesn't happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

Radiometer currently utilizes an on-premise Quality Management System (QMS) software, which reaches end-of-life end of 2025.

The IT QMS Project Manager for Radiometer is responsible for heading the replacement of the MasterControl on-premise system with a new QMS IT system before the end of 2025. This position will also be responsible for managing the support and potential changes to the current system.

The IT QMS Project Manager will take a leadership role in engaging with external companies and internal business resources to ensure a successful migration. The project manager will also lead the current MC support team, which consists of a full-time supporter, an application manager, and an IT specialist.

Included in the responsibilities will also be expansion of the future QMS IT system to include relevant areas and functionalities such as the CAPA process, non-conformance process, audit management, and potentially complaint management. Other systems that may fall under the scope of a QMS, like data archiving systems, are also under consideration for this department.

To excel in this role, a robust grasp of IT SaaS solutions and QA processes within Pharma or MedTech is essential for effectively bridging these domains.

This position is part of the IT compliance department located in Brønshøj and will primarily be on-site.

At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the IT QMS Team and report to the Director of IT Compliance responsible for Radiometer QMS IT Systems. If you thrive in a key role and want to work to implement a world-class QMS IT System and organization—read on.

In this role, you will have the opportunity to:

  • Act as technical project lead for QMS IT System implementation, migrating from our current solution.
  • Act as technical project lead for new future QMS IT system functionality implementations.
  • Manage third party vendors, like QMS IT system supplier, implementation partner, etc.
  • People management, leading and developing a small team of QMS IT System professionals.
  • Continuous resource allocation and planning within the department and with relevant external partners hence ensuring effective and timely handling of services as committed.
  • Define and drive roadmaps for IT QMS systems and drive cross departmental implementation through stakeholder management.

The essential requirements of the job include:

  • 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.
  • Experienced people lead, who can motivate and lead technical professionals and experts.
  • Strong communication skills and fluent in English.

Travel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel when needed. No more than 10% of your time is expected.

It would be a plus if you also possess previous experience in:

  • Experience in collaborating with IT vendors specializing in SaaS business solutions.
  • Understanding of Good Documentation Practice and quality processes (Change control, NC/deviations, CAPA, etc.).

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

Application

We continuously assess candidates and invite them for interviews, so please don't hesitate to write and send in the application. The recruitment will be completed as soon as a suitable candidate is found.

We look forward to seeing your application.

We thank you for your interest.

#J-18808-Ljbffr

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