PFS devices and Primary Packaging QA
Hillerød, Denmark
Are you motivated to serve as the ambassador for millions of patients worldwide, safeguarding their safety? Are you a solution-oriented individual with a strong passion for Quality Assurance (QA)? Do you find inspiration in actively utilizing quality as a driving force when integrating medical device and pharmaceutical development projects, particularly in Primary Packaging and Combination Products?
If yes, then you might be the ideal fit for our Final Product Development Quality team in Hillerød. Apply now for our Senior Quality Assurance Professional position!
Your new role
As a Senior Quality Assurance Professional, you will play a significant role in our QA development area, contributing to both existing and upcoming projects, supporting them in implementing suitable quality strategies and reviewing and endorsing design control documents. Your involvement will encompass navigating medical device and pharmaceutical regulations throughout the entire Primary Packaging and Combination Product development process, guiding it from inception to product launch by contributing to project planning and ensuring successful milestone delivery at each stage. This role gives the opportunity to collaborate with a diverse range of stakeholders at Novo Nordisk and external development partners, and to set the direction for quality in line with both internal and external requirements.
Your key responsibilities will include:
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-Providing quality oversight of the Primary Packaging and Combination Product development process.
-Reviewing and approving development documentation regulated by GxP requirements.
-Handling situations independently, applying your subject matter knowledge to identify best practices and drive improvements to Quality Assurance processes.
-Playing an active role in sharing knowledge and learnings to empower your colleagues.
-Providing active assistance during authority inspections and internal audits, both in the practical setup and in supporting the projects in presenting documentation.
Your new department
Final Product Development Quality is accountable for covering all quality aspects in the development portfolio of Primary Packaging, Combinations Products and Medical Devices, as well as projects investigating new paradigms for drug delivery systems. Further, we work on Quality Management System activities, quality oversight of our suppliers, and host inspections. We are an international team of 40+ passionate Quality Assurance experts with diverse backgrounds of which the vast majority is based in Hillerød, Denmark. Along with the rest of the Final Product Development area, we have a high focus on patients and take pride in having a significant impact on the life of patients by ensuring high quality, safe, and effective products.
Your skills and qualifications
We are looking for a profile with strong scientific foundations, solid industry experience, and the ability to translate regulatory expectations into practical, compliant processes.
To succeed in this role, you have:
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-A degree in pharmaceuticals, chemistry, engineering, or a relevant field with a strong emphasis on quality.
-Substantial experience in the pharmaceutical industry.
-A proven track record in interpreting regulatory requirements, ideally well-versed in standards such as: EU GMP – part I, II, III, and IV, 21 CFR 210/211/820; 21 CFR part 4; Ph Eur, USP.
-Proficiency in written and spoken English at a professional level.
-Experience in actively participating in audits and leading them is advantageous.
Furthermore, you actively and constructively engage stakeholders and can navigate cross-organizational landscapes. Your ability to swiftly comprehend situations and dilemmas, combined with a solution-oriented approach to introducing innovation within procedural and regulatory frame, is a strength.
You also possess the skill to translate regulatory guidance into operational practice, furthering the development of our products. Clear communication and the ability to present your perspective using factual information when necessary to ensure regulatory compliance or patient safety is crucial. Keen eye for process improvement, coupled with the drive to effect change, is highly valued.
Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you’re not just starting a job – you’re becoming part of a story that spans generations.
More information
For further information Dean Kloe at kloenovonordisk.
Deadline
15 March 2026. (Applications are reviewed on an ongoing basis).
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.
At Novo Nordisk, we’re not chasing quick fixes – we’re creating lasting change for long-term health. For over 100 years, we’ve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what’s possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we’re making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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