CMC API Quality Coordinator

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Quality Coordinator in CMC API Development – for newly established project unit within QMS and cLEAN Do you want to build and establish the right level of quality in an area within Novo Nordisk that bridges between early research and production? Do you like to have a broad stakeholder palette and securing everyone is on board regarding compliance and GMP? Do you have the seniority and experience to set direction in an encouraging and positive way? The direction is set based on analysed data, spotted trends, QMS requirements but also in a dialogue with the team and the whole area. Interested? Then, this is your chance to take the next step in your career and gain more responsibility for processes and quality in all departments within CMC API Development in Novo Nordisk. Background CMC API development (API Dev) is growing and expanding the project pipeline. In addition, the area is building up a new Manufacturing Development department focused on small molecules. This means departments currently working with GMP need more support with QMS activities and a new department need help with building a QMS system bottom-up. Therefore, a new QMS and cLEAN unit is being established – you will be part of establishing this new cross-organisational unit. As the unit is growing, new tasks are added, and you will help finding solutions and setting the direction. The position The unit will be one-point-of-entry for securing and coordinating QMS activities from global procedures, being responsible for audits and inspections (conduct planning, execution and follow-up) and support with quality and training related activities. Specifically, the unit and your main responsibilities will be to:
  • Expand and build the QMS within API development
  • Strengthen the QMS by ensuring compliance of our working processes and procedures in the departments working with GMP
  • Be the go-to unit on quality subjects; you actively identify and drive quality improvement initiatives, and support as needed by applying systematic problem-solving, process mapping, or other LEAN methodologies
  • Join the planning, preparation, and execution of audits and inspections in API Dev and support during audits and inspections.
  • Help with complex deviations and change requests
  • Quality monitoring setup
  • Content overview
  • Security risk assessment
  • And other quality reporting documents owned at API Dev level
    • Qualifications To thrive and succeed in this role, we expect you to have:
  • A scientific academic degree in engineering, biology, chemistry, or another relevant discipline at master level or above
    (scientific areas cover: chemistry, cell banks, virology, isotope technique, protein science and expression/cultivation)
  • Minimum 3 to 5 years of relevant working experience with API Development
  • Minimum 3 to 5 years of experience within GMP and compliance
  • Preferably c LEAN certified
  • The ability to manage competing timelines and priorities
  • Strong problem-solving and organizational skills
  • Excellent written and verbal communication skills with expert proficiency level using Microsoft Word, Excel, and PowerPoint
  • Experience with project management in a multidisciplinary organization is required, including cross-functional communication and stakeholder management
    • As a person, you are curious and have a quality mindset. You like to take responsibility, both within the team and independently. You make decisions that balance quality requirements, authority expectations, and business needs. You describe yourself as pragmatic with a proactive mindset and strong collaboration skills. You need to be fluent in English, whereas Danish is not a requirement. About the department As the Quality Coordinator, you will join the Virology and Raw Materials department in Bagsværd, Denmark, and collaborate with all GMP-related departments in the CVP area, including virology, isotope chemistry, cell banks, and project office. The Virology and Raw Materials department consists of over 50 colleagues organized into four teams and is responsible for ensuring the virus safety of our API's and qualifying GMP materials for clinical production. While this position is primarily office-based, we offer flexibility to work from home when the tasks at hand allow. 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. Contact For further information, please contact Director Kristine Buch Uldahl at +45 3077 5640. Deadline 7th August 2023 You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV. This makes for a better and more fair process. 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.


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    Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 9.6.2023, men kan have været deaktiveret og genaktiveret igen.

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