Experienced QA for Local Manufacturing CMO

Experienced QA for Local Manufacturing CMO Do you want to work in one of the most interesting and challenging areas in Novo Nordisk? Are you passionate about Quality Assurance, Quality Management Systems (QMS)? Are you eager to take your professional carrier to the next step? Do you want to have international business impact and are you ready to make a difference? If your answer is yes and you have the ability to engage, set quality and compliance direction and mobilize people with different cultural backgrounds in an ever-changing international setting, you could be our new colleague in our Local Manufacturing CMO team. The job: The objective of the current position is to ensure QA oversight by visits, compliance checks, quality review meetings and approval of documents. This includes approval of validations, change requests, deviations and recommendations for batch release. As well as supporting in all quality matters. Involvement in projects will be an option after capabilities are acquired for the daily operations. As QA you will together with a highly skilled QA team be responsible for delivering best-in-class Quality Assurance and work with our colleagues in Line-of-Business to ensure highest quality at our CMOs production. • You will take QA responsibility of one of our CMO’s and be handling daily operation of your CMO • You will be part of projects including the QA role during validation and re-validation • You will train the local CMO QA organization to maintain and improve compliant operation • You will act as both coach and mentor at the CMO’s. Building the Quality mind-set as well as Quality and Compliance culture at the CMO is an important part of the position • You have the ability to oversee and manage high level tasks in an international and often cultural and politically challenging environment • You must have strong cross-functional skills as well as an ability to engage and energize local employees at the CMO’s • You have experience and high level of knowledge within Quality Assurance, QMS and EU GMP. The position will be part of the organizational set-up in LM QA DK currently consisting of nine colleagues working closely together. LM QA currently cover our CMO locations in Saudi Arabia, India, Bangladesh, Belarus, Singapore and soon to come a new country. At present 3-5 weeks of travel pr year to one of the CMO’s is expected. We use virtual and written communication in the daily operation. We expect you to be able to handle situations independently, apply your subject matter knowledge, identify better practice, create improvements to processes, share knowledge and to let your colleagues learn and shine. Qualifications • M.Sc within Science, Engineering, Pharmacy, Chemistry, Biotechnology or similar • You have preferably a minimum of 5 years of relevant experience working with either aseptic, assembly or packaging production in QA organizations within pharmaceutical manufacturing • You have experience with EU GMP requirements, business understanding within pharmaceutical products, qualification and validation, collaboration in international environment, relation building and stakeholder management • As a person, you have a high level of energy and drive, are open-minded and positive attitude, want to make a difference and are eager to learn. You have a well-developed Quality Mind-set and an ability to set direction, engage and energize employees in the task/challenge at hand • You can understand and collaborate in an international environment with respect for cultural differences. You are diplomatic and have a mature appearance and style which demonstrates authority and good judgement • You must be fluent in English, both written and spoken. Knowledge of other languages is an advantage. About the department Local Manufacturing QA (LM QA) is a part of Contract Manufacturing & Sourcing, Devices & Sustainability in Product Supply, Novo Nordisk A/S. LMQA is responsible for Quality Assurance of Novo Nordisk’s local manufacturing CMO’s and local NN sites. One of the primary roles of LM QA is to deliver QA support and set direction for Contract Manufacturing Organizations (CMO’s) in countries where local presence is required to maintain market access. The job is in Søborg, Denmark. Things move fast in our unit, and the daily operation is dependent on cooperation with many internal and external stakeholders from all over the world. Working at Novo Nordisk At Novo Nordisk, you will have the opportunity to build a life-changing career in a global business environment. From research and development, to manufacturing, marketing, and sales, we strive to improve quality of life for more than 400 million people living with diabetes or other diseases. Contact For further information, please contact Senior Quality Manager Asger Laurberg Vig +45 30752770. Deadline June 11th 2023 We will review applications received on an ongoing basis, so do not hesitate to apply today. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Mandatory footer (automatic via SF) 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. 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.