Senior GMP Coordinator

3 days ago


Hillerød, Denmark Novo Nordisk AS Full time

Would you like a central role in a dynamic department with tasks that involve close collaboration with many stakeholders on a daily basis? Do you have experience with inspections and authority interactions, and a solid understanding of good manufacturing practice? Are you passionate about compliance, structure, and continuous improvements? Are you self-motivated, structured and have an efficient nature, and do you can see solutions in a broader perspective?

If yes, you might be exactly the one we are looking for to join our team. Apply today

The Position

We are looking for a senior GMP coordinator who knows this role well and can drive quality related improvements as well as audit and inspection setup within the 4 Departments in 25K.

Your role will be to maintain the audit setup and secure efficient follow-up on any actions. In addition to this, you will have the opportunity to collaborate with other quality coordinators PS API M4 to handle exciting tasks across the area, e.g. focusing on improving performance on quality KPI’s.

Your role will be to:

  • Plan, prepare, handle and follow up on authority inspections and internal audits in 25K.
  • Drive and coordinate quality improvements in 25K.
  • Responsible for GMP training and contribute to the understanding of GMP in 25K.
  • Responsible for delivering and analyzing data to support production KPIs.
  • Drive and participate in quality or compliance related projects and contribute to optimization of quality processes in 25K and across the CVP area.
  • Fill the role as Data Integrity Steward in the ongoing Novo Nordisk Data integrity project.

Qualifications

To be considered for this position you must have:

  • An academic degree (BSc or MSc) in natural science, engineering or similar.
  • Preferably +5 years of experience from similar position within Novo Nordisk.
  • You are familiar with complex quality processes and have experience from Good Manufacturing Practice (GMP) regulated areas.
  • Experience with ISO and/or LEAN is an advantage, as it is an integral part of our everyday work.
  • Proficiency in both English and Danish is a requirement.

On a personal level you thrive and get motivated by working with and across multiple levels in the organization, whilst you are known for your excellent collaboration and communication skills and ability to set direction. You are solution oriented and work systematically, proactively and strive for simplicity in processes, while taking pride in solving your tasks and challenges as close to the process as possible, with close involvement of your stakeholders.

About the Department

You will be part of a dynamic business area that produces Active Pharmaceutical Ingredients (API) for patients across the world.

PS-API M4 is an area in Novo Nordisk that will be at the centre of many new initiatives in the coming years. We manufacture a range of innovative products for our patients living with diabetes, haemophilia, hormonal imbalances and other impactful chronic diseases. API Manufacturing 4, 25K Multi Product Facilities consists of around 200 employees split into different teams and staff function. We are situated in Hillerød and produce various APIs which are used to treat patients all over the world.

Site Hillerød is an innovative and fast-growing production site. With over 4,000 talented employees, we work together to drive change for people living with serious chronic diseases. The site is located in beautiful natural surroundings, and we offer a diverse array of career paths at all educational levels. Join our vibrant community at Site Hillerød and ramp up your career while we ramp up our production

Contact

If you would like to know more about the position, please contact Senior Manager, Christiane Wiendahl, on +45 30794862.

Deadline

29 January, 2025. But we are reviewing candidates on an ongoing basis, and we will close the selection process once we have the right candidate.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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