QA Project Manager/QA Specialist in CMC QA

Are you looking for an exciting opportunity to use your strong quality mind-set and scientific background within QA, GMP and CMC in Novo Nordisk’s critical drug development projects while at the same time use your project management skills? Are you motivated by defining the quality strategy for all drug development projects in our pipeline ensuring the quality from early development until submission to the authorities? Do you want to play an important role in ensuring the quality and safety of products for clinical trials? Then this position as CMC QA Project Manager is for you! The position CMC QA Project Management department consist of 12 highly skilled employees. We are looking for a new colleague to be part of our team and cover the quality perspective in drug developments projects across all the therapeutic areas in Novo Nordisk. You will manage the quality perspective in CMC projects with high complexity. You will get a broad range of exciting challenges with impact on the results for the SVP area feeding in to your personal and professional development. Our working environment is flexible, dynamic, and informal with a strong culture of cross-functional collaboration. In your role as a CMC QA Project Manager, you will actively take part in project core teams, you will use your empowerment to take decisions and have the QA responsibility and quality oversight for projects going into clinical trials in all phases until hand-over to Product Supply when the product is launched. You will act as one point of entry to CMC QA from Research & Development, CMC Development, Regulatory Affairs, external partners as well as from our QA colleagues across Novo Nordisk. In some projects the production is outsourced to contract manufacturer organisations (CMOs), where you will act as an QA Outsourcing Manager. In this role you will drive, coordinate and facilitate quality related activities (e.g quality agreements, document review etc.) between the CMOs and colleagues in CMC. In your daily work you will plan, coordinate, facilitate and follow-up on QA project activities to ensure timely delivery. You will include quality aspects in project strategies and development plans, and you will proactively address potential quality problems in development projects. You will also - in cooperation with your colleagues - identify and contribute to strengthening and simplify our working processes in CMC QA and towards our many stakeholders. Qualifications We are looking for a colleague that has QA and/or Project Management experience within CMC drug development projects in regulated environments (GMP regulated). You must have a profound knowledge of the important aspects of CMC and GMP related regulations, requirements and guidelines for pharmaceutical development and production for clinical trials. This is needed to balance our demands for agility and compressed timelines and the requirements from authorities without compromising on quality. You hold a master’s degree within pharmacy, biotechnology or similar. Furthermore, you must have solid experience within Novo Nordisk or from a pharmaceutical company, preferably from an advanced QA position such as QA specialist or QA/CMC project manager within the field of QA and/or CMC. As a person, you are open-minded and eager to find solutions on complex quality related challenges which must be in compliance with GMP regulations. Managing a large network of people is something that drives you. You are quality-and goal-oriented all of which will support your success in this role. You have great collaboration and communication skills on all organisational levels, and you are a self-driven and independent person with a high sense of responsibility and initiative. You thrive working in a dynamic environment, where teamwork is on the top of the agenda, and you enjoy working with many different stakeholders. Written and verbal communication skills in English is required. About the CMC area and department CMC Development is the link between research and production for market. CMC Development is supplying products needed for Novo Nordisk’s clinical trials around the world. CMC QA is the quality area which together with CMC Development ensures that quality is incorporated all the way. CMC QA consist of 6 departments, hereof 4 operational departments placed in Bagsværd and Måløv, 1 support department and 1 project management department (our), both based in Bagsværd area. CMC QA Project Management work with assuring quality and compliance of all Novo Nordisk products for clinical trials. We also have the responsibility of creating quality agreements with contract manufacturers across the globe. In our department, we value teamwork and diversity, and we will make sure you, as a new employee, feel welcome and integrated. Further, an individual training plan will be made for you together with your mentor. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our careers is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Director Rikke Wissing Jensen at +45 3075 1566
Deadline
Review of applications and interview will be held ongoing with deadline April 11, 2023 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.