Risk Manager for Primary Packaging

The position

As Risk Manager, your primary focus will be on the Life Cycle Management (LCM) of the Risk Management documentation packages related to Primary Packaging (PrimPack). You will be working in an inspiring scientific environment with highly engaged colleagues and in close collaboration with different areas such as R&D, Production and Supply Chain. Tasks will include: 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 Proactively ensuring that processes are compliant with internal and external requirements. Governing the process for LCM of PrimPack product risk documents including readiness for periodical reviews Overseeing the process for transfer of the risk package to PrimPack Injectables Qualifications We are looking for a candidate who: Holds a master’s degree or Ph.D. in engineering or another relevant field within the natural sciences. Is experienced working in GMP environment, with risk management tools and methodologies, system engineering, safety risk management and quality specifications. Has experience within medical device development, and a strong understanding of medical device regulations and standards Has a proven track record of successfully managing risk within medical device development projects from concept to commercialization. Additionally, the successful candidate: Is fully proficient in written and spoken English. Is highly conscientious and works in a very structured manner. Possesses excellent communication and leadership skills, with the ability to effectively collaborate with cross-functional teams, stakeholders, and external partners. Has a positive, forthcoming attitude and is motivated by teamwork. 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 . Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here – to ensure that people can lead a life independent of chronic disease.