Do you want to take part in the implementation of new primary packaging for Novo Nordisk and play a key role in its maintenance? Are you ready to take on the challenge of setting the direction in the challenging field of materials for use in GMP production? Are you able to collaborate broadly and work independently? And do you thrive in a work environment with many simultaneous and varied tasks? If yes, apply today for a life changing career!
The position
As a Risk Manager, you will be working in an inspiring scientific environment with highly engaged colleagues and in close collaboration with people from different areas such as R&D, Production and Supply Chain.
Your main focus will include:
Life cycle management of Risk Management documentation packages
Reviewing and updating Risk Evaluation and Control Agreements when implementing new or modified Drug Products or combination products
Reviewing and updating Risk Evaluation and Control agreements when new or modified manufacturing and production processes are implemented
Ensuring that Risk management processes are compliant with internal and external requirements and aligned with Risk management processes
Governing the process for LCM of PrimPack Injectables product risk documents including periodical reviews
Overseeing the process for transfer of the risk package from DDS to PrimPack Injectables
Secure integration with Critical Quality Attributes for Drug products and Combination products.
Ensure that relevant documentation is kept updated.
Qualifications
We are looking for a candidate who:
Hold a master’s degree or Ph.D. in engineering or any other relevant field within the natural sciences.
Are experienced working in GMP environment, risk management tools and methodologies, system engineering, safety risk management and quality specifications.
Have experience of Risk Management within medical device development
Possess a strong understanding of medical device regulations and standards
Can demonstrate proven track record of successfully managing risk management within medical device development projects from concept to commercialization.
Furthermore, you
Are fluent in written and spoken English
As a person, you work in a structured manner and take ownership of your assignments. You have strong technical and analytical skills, are result-oriented and take pride in delivering on your milestones. You possess excellent communication and leadership skills, with the ability to effectively collaborate with cross-functional teams, stakeholders, and external partners.
And you motivate your colleagues with a positive, forthcoming attitude. You work well independently, although it also motivates you to work together with colleagues and stakeholders across functions and departments.
About the department
You will join the Material Manufacturing Development – Primary Packaging Department in Product Supply, Sourcing Operations.
You will be working at the company headquarters in Bagsværd, Copenhagen with an environment characterized by innovation, openness and highly engaged colleagues who work dedicated to help us change lives for the better for patients around the world.
We consist of approx. 50 employees organized in 4 teams and are continuously growing. We are responsible for implementation of complex Primary Packaging materials and maintaining documentation on existing materials. We cooperate with a variety of functions, including CMC, Device R&D, QC laboratories, QA, various Novo Nordisk production sites around the globe, and a range of external suppliers and contract manufactures (CMO).
The Department is currently located in Bagsværd and will relocate to Høje Taastrup in 2026.
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