Senior QA professional for Qualification/Validation

Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? Would you like to use your solid QA and validation experience in a project context? 
Then we can offer you a unique position with a lot of impact in a dynamic environment and an opportunity to really develop your skills professionally and personally, read more below and apply! 

The position 
Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA is looking for two new colleagues to be part of an optimization project that is already running at full speed.

The CMC API pilot facilities are expanding their production capacity for clinical trials and phase 3 productions. Weare looking for new QA colleagues to work with our 7 dedicated and highly skilled Project QA´s allocated for this project. 

In this role, you will be responsible for: 

When Warp Speed Project ends (ultimo 2025), the team will continue supporting the API area in CMC. You will - in close cooperation with your colleagues - identify and contribute to strengthening our production facilities compliance level and contribute to find solutions for ad hoc questions and challenges within GMP compliance, and you will challenge and approve documentation regarding qualification of facilities and equipment as well as other supporting documents for the Pilot facilities. 

Qualifications 

An important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues with a necessary and sufficient mindset. You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity. 

To qualify for this role, you: 

Experience within IT Quality qualification will be considered an asset but is not a requirement.

On a personal level, you can work with several tasks at the same time and can make decisions and follow up on quality related problems, demonstrating the ability to take full ownership of tasks and a strong commitment to meeting objectives and delivering high-quality results. 

You are a self-driven and independent person with a high sense of responsibility and initiative, other than showcasing interpersonal skills, with the ability to clearly and precisely communicate complex matters to stakeholders. 

Finally, you thrive in a dynamic environment, where teamwork is on the top of the agenda and you like working with many different stakeholders.

About the department 
CMC API QA is a department which employ 38 skilled and motivated colleagues divided in 4 teams based in site Bagsværd. We work with assuring quality and compliance of the CMC API facilities & equipment as well as the release of raw materials, cell banks and API for clinical trials. We participate as QA for smaller or bigger investment projects to make our Pilot facilities more prepared for the future. 

We are continuously improving the quality of work, and we optimise our methods and processes to increase simplicity across CMC QA and CMC Development. We make a difference in the lives of people participating in clinical trials in Novo Nordisk A/S, by ensuring that the products they receive are safe, of the highest quality and produced in compliance with legislation. 

Our department values teamwork, diversity, and humour and we will make sure that you, as our new employee, feel welcome and included. A thorough individual training plan will be made for you together with your mentor.