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QA professional for IT/automation - expansion project at Novo Nordisk

Would you like to set the right bar for IT systems of new products coming into BRD (Biotech and Rare Disease) API DK ? Do you like being a part of a big project as QA professional with knowledge of IT systems in GxP data-generating processes? Then a position as QA professional with focus on IT systems in our QA team might be the position for you!
We can offer a unique role where you will define and establish digital infrastructure in a team with great communication and support.

The position

As QA professional for IT/automation, you will play a crucial role in a major project. Your key task is to set direction and to ensure facilities and processes that support products of the highest quality to serve our patients. As a wide range of new products and technologies are entering BRD (Biotech and Rare Disease), we seek additional competencies and knowledge of Process/Facility IT Validation to assist our department.
In your role you will:
  • Help set Q direction on IT on a major project.
  • Review and approve validation/IT validation deliverables
  • Advice the line of business on IT related topics

The job is based primarily in Hillerød but meetings in Gentofte or Copenhagen will occur as well.


To succeed in this position the following experience and qualifications are required:
  • Hold a master’s degree within a relevant field e.g. Engineering, Pharmacy, or similar
  • Min. 1 year of experience with qualification and validation of IT systems/equipment and data generating processes within the pharmaceutical/biotech industry
  • You have a good understanding of GxP data integrity principles and data lifecycle within biotech production and know how to communicate and apply these principles in everyday work.
  • Experience/knowledge about regulatory requirements for computerized systems
  • Experience/knowledge about implementation and handling of IT quality management systems (QMS) such as deviations, QMTs, change control, risk assessment and SOPs.
  • Have proven experience, preferably QA, with IT and validation in the pharmaceutical industry and Good Manufacturing Practice
  • Have good stakeholder management skills and table coordinating- and collaboration skills at all levels of the organization

On a personal level, you are an open-minded person with a good sense of humour and a confident attitude. You must be willing and open to make decisions and be able to stand firm towards stakeholders at all levels when required to ensure compliance, while at the same time being able to build good and personal relationships. You thrive by planning and setting an honour in implementing and performing tasks according to the plan.
You are detail-oriented and a strong ambassador of a quality mind-set, but also able to apply pragmatic approaches and seeing things from a different angle when needed.
Moreover, we are looking for an individual who is flexible combined with the ability to increase simplicity in the processes. We appreciate a curious, innovative, and solution-oriented approach to overcome challenges.

About the department

BRD QA API Denmark is in Gentofte, Hillerød and Kalundborg. We are assuring the quality of the active ingredients, going into all our life-saving biotech products, we are app. 50 committed colleagues. Our products are manufacture through complex chemical and biotechnological processes requiring a high level of expertise, commitment, and engagement from all of us. The processes include cultivation, recovery and purification. We are, together with the production departments, producing at full speed in existing facilities, while building and ramping up new state of the art additions to keep up with demand and new Novo Nordisk products. We bring value to patients by delivering the purest possible high-quality API made in compliance with GMP. We drive change by always looking for improvements within our processes, but also in the way we work together to make our products reach as many patients as possible.
In our department the teams have a high level of self-governance, and the working relations are informal. We value good humour and an open and honest culture. We have a high focus on a great work-life balance, with the flexibility to work from the office and remote.


Do you want to know more about position please contact Jane Frederiksen on +45 3079 9796.

Application deadline

Deadline to apply for this position is March 28th 2023.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
Interviews will be held on an ongoing basis.
Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been identified.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.
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.
Attention: When applying for this thesis, remember that there are specific regulations and requirements that needs to be met in order for you to include it as part of your education. For more information on criteria, please contact your local student advisor as outlined here Faculty student advisors (in Danish)

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