Senior Project Manager, Global Expansions

Found in: Talent US C2 - 2 weeks ago


Denmark, United States Novo Nordisk Full time

The position

As a Senior Project Manager and WPO for the Formulation Work-Package, you will play an essential role in the successful implementation of a new technology standard that covers the Formulation aseptic processing area. We create the future standards. Your responsibility will be to drive the Work-Package deliverables, while supporting the overall project goals of delivering a world class solution in a time frame that challenges the traditional approach. This requires engaging with the Work Package Owners (WPO) of other technical areas, Subject Matter Experts (SME), international stakeholders and harvesting the inherent experiences of the company and combining the input with state-of-the-art aseptic production technology. As part of your work track, we expect the following content to be included: Project management of tasks within your work package including design of future technical solutions and process flows with focus on adherence to the aseptic standards and authority requirements. Preparing documentation and management of test execution and validation of activities within your area of responsibilities (FAT, SAT, IQ/OQ). Coordination with Quality Assurance (QA) and Regulatory Affairs (RA) and coordinating responsibility for designing and implementation equipment. Design and implement training setup for inspection and other relevant compliance activities for the isolator filling line and related process. Coordination and alignment with local and global WPO peers. As many of the tasks are new, the designing and describing of the processes will all be executed in close collaboration with pharma consultants, engineering SME’s and the other project members or specialists within the area. Furthermore, you will have the opportunity to travel to our global sites which includes sites based in Denmark, France, US, Brazil, and China. 20% travel is expected for the position. Qualifications To be successful in this role, you need to have academic degree within natural sciences, engineering or similar and have minimum 5 years of relevant experience. Additionally, you need to have: Project management experience of technical and complex projects. A flair for leadership and the ability to create results in a global stakeholder landscape with many different actors. A quality mindset and a drive to create the “right” solutions while challenging the status quo supported with data. Experience with aseptic process production design and GMP is considered a huge advantage but not a requirement. An excellent command of verbal and written English As a person, you are skilled at establishing relationships. You are proactive, solution-oriented and knowledge sharing is natural to you. You work systematically and are committed to your work and your colleagues. You are naturally good at collaborating and communicating, also across professional groups, you can manage a high workload at times without losing sight and you have a can-do mindset. Furthermore, you embrace professional and personal diversity. Additionally, you have excellent communication skills to build relations cross functionally and globally. For this position, you are required to be fluent in spoken and written English. As you will be working globally with the Danish sites, France and China, language skills within these areas would be advantageous. About the department Technology Standards is a department in the newly created area of Fill & Finish Expansions which is anchored within Product Supply, which globally accounts for , of Novo Nordisk’s , employees. The responsibility of Fill & Finish Expansions is to plan and execute the establishment of new aseptic filling capacity across the global manufacturing network within BioTech and Rare Diseases (BRD) and Injectable Finished Products (IFP) for new filling platforms while ensuring harmonisation and global standards. Across the different roles there is a distinct global aspect as the end goal is a global standard and best practice, and working with multiple sites, cultures and traditions will be a key element. 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.
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