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Are you looking for an exciting opportunity to use your strong quality mind-set and scientific background on critical development projects while at the same time use your project management skills? Are you ready to take the step from an operative position to become CMC QA Project Manager working at QA specialist level, where you will play an important role in ensuring the quality and safety of products for clinical trials? Then this position might be just the right career move for you.

We will ensure that you get an adequate onboarding to the job, so that you will be able to act as a CMC QA Project Manager with independent QA responsibility for your own Novo Nordisk projects going into clinical trials.

The position

We are expanding CMC QA Project Management department consist of 12 highly skilled and motivated employees to cover the quality perspective in all the 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.

As a CMC QA Project Manager, you will have the QA responsibility for your own 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 and from Regulatory Affairs. In some projects the production is executed at a contract manufacturer, where you will be QA Outsourcing Manager.

In your daily work you will plan, coordinate and follow-up on QA project activities to ensure timely delivery. You will include quality aspects in project strategy 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

You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production for clinical trials. This is needed to balance the research area demand for agility and compressed timelines and the requirements from authorities without compromising on quality.

You hold a Master degree within pharmacy, biotechnology or similar and it is key, that your education is supplemented with solid experience from a pharmaceutical company, preferably from a QA position and/or with experience within clinical trials.

You have great collaboration and communication skills, and you are a self-driven and independent person with a high sense of responsibility and initiative. You thrive 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.

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 contracts 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
13th November 2022.

Review of applications and interview will be held on an ongoing basis

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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Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Bagsværd.

Jobbet er oprettet på vores service den 30.9.2022, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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