Quality Management System Strategist

4 weeks ago


Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

We are seeking a highly skilled Pharmaceutical Quality Expert to join our team at Novo Nordisk A/S.

About the Role

As a GMP Compliance Specialist, you will be responsible for ensuring high-level quality and compliance by setting the right strategy and standards in maintaining our Quality Management System (QMS).

In this role, you will have the opportunity to develop and improve the way we work with quality by setting the direction and creating a strategy for QMS handling.

Main tasks will include:

  • Be the go-to person on quality subjects; you actively identify and drive quality improvement initiatives, and support as needed by applying systematic problem-solving, process mapping, or other LEAN methodologies
  • Ensuring high-level GMP overview and report quality trends to management
  • Driving preparation for, participate in and follow-up on authority inspections and internal audits
  • Responsible for the Quality Management Review
  • Supporting daily operations and ensure the relevant level of GMP and training

You will work closely with the entire GMP network both locally and on a global level, and your stakeholders at CVPs and SVPs QMS partner level.

About You

To succeed in this role, you have:

  • A master's degree in pharmacy, biochemistry, production engineering or similar
  • Extensive experience from the pharmaceutical industry, in roles related to QMS, manufacturing, QC or QA
  • Strong understanding of GMP regulations and requirements
  • Experience with project management, and preferably are LEAN certified
  • Full professional proficiency English, while Danish is an advantage, but not required

The estimated salary for this position is 95,000 - 120,000 DKK per year, depending on experience.

About Us

At Novo Nordisk A/S, we are dedicated to making a difference in the lives of people affected by diabetes and other serious chronic diseases. Our team is passionate about developing innovative solutions that improve patient outcomes and quality of life.



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