Qualified Person for Clinical Assembly Production
Category: Quality
Location:
Hillerød, Capital Region of Denmark, DK
Join us as a Qualified Person in Device Manufacturing & New Product Introduction QA (DMN QA) and play a pivotal role in ensuring the quality and safety of products for Novo Nordisk clinical trials. This opportunity allows you to make a meaningful impact on patient care while advancing your career in a dynamic environment.
Your new role
In this role, you will work as a QP and Compliance Specialist, covering clinical assembly batches and you will be part of a team of 8 engaged and highly skilled QA colleagues. The area we support is the assembly and release of products for Novo Nordisk clinical trials run worldwide. We play a crucial role in delivering products at the right time in the right quality to ensure patients enrolled in clinical trials can rely on our company.
In this role, you will work as a QP and Compliance Specialist, covering clinical assembly batches and you will be part of a team of 8 engaged and highly skilled QA colleagues. The area we support is the assembly and release of products for Novo Nordisk clinical trials run worldwide. We play a crucial role in delivering products at the right time in the right quality to ensure patients enrolled in clinical trials can rely on our company.
Your main responsibilities as a QP and Compliance Specialist will be to:
- Act as a QP to release drug and combination products from our assembly facility for clinical trials.
- Act as a QP and as a role model setting direction in the batch status assignment and release process for a dedicated team of QP delegates.
- Act as a Compliance Specialist and as a role model setting direction in the compliance processes (e.g., QMS) for dedicated QA colleagues in the department
- Support the clinical assembly facility and processes with validation tasks
Depending on your level of experience and ability to act across different subject matters, you will contribute to improvement projects both internally with our stakeholders and across the Novo Nordisk Quality organisation.
Your new department
At DMN QA, we are a team of 25+ highly qualified professionals based at our Hillerød site, with diverse backgrounds and interests. We are responsible for ensuring the quality and compliance of all processes in DMN, including testing and manufacturing processes.
At DMN QA, we are a team of 25+ highly qualified professionals based at our Hillerød site, with diverse backgrounds and interests. We are responsible for ensuring the quality and compliance of all processes in DMN, including testing and manufacturing processes.
We take pride in our work and are constantly seeking to improve our competencies and processes through a focus on simplicity and collaboration. By joining our team, you will have the chance to make a real difference in the lives of patients through the development and life cycle management of crucial medical devices.
Your skills and qualifications
The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems.
The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems.
To succeed in this role, you:
- Hold a master’s degree in pharmacy, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry, or biology. Please note that your education must support the requirements to a “Qualified Person” from the Danish Medicines Agency (Lægemiddelstyrelsen), therefore while applying we ask you to upload your diploma.
- Have 5 or more years of experience within a GMP regulated manufacturer, preferably in quality assurance.
- Have experience with batch release/status assignment.
- Are fluent in English.
Prior experience with medical devices and combination products would be an advantage.
On a personal level, you are ambitious and ready to take responsibility for building strong competencies within our team and fostering trustful relationships across the organisation. You can use your excellent cooperation skills when you manage your stakeholders to ensure solutions that will meet both requirements and stakeholder’s interests. You want to make a difference and are eager to learn. Finally, you are well-organised and have a flexible, but firm approach when making decisions.
On a personal level, you are ambitious and ready to take responsibility for building strong competencies within our team and fostering trustful relationships across the organisation. You can use your excellent cooperation skills when you manage your stakeholders to ensure solutions that will meet both requirements and stakeholder’s interests. You want to make a difference and are eager to learn. Finally, you are well-organised and have a flexible, but firm approach when making decisions.
Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.
What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.
More information
For further information, please contact Manager, Sophie Smietana at +45 4116 4053
Deadline
25 August 2025.
Novo Nordisk is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.