Advanced QA Professional

Are you passionate about quality and excel in building strong relationships in a dynamic environment? Do you thrive navigating complex stakeholder landscapes, with a strong belief that collaboration leads to greater success? 

If you value good team spirit and aspire to play an important role in ensuring the quality and safety of products for clinical trials, we look forward to welcoming you in the Chemistry, Manufacturing, and Control (CMC) Active Pharmaceutical Ingredient (API) QA department. Apply now!
 
The position
As an Advanced QA Professional, you will be responsible for ensuring best-in-class quality assurance in the qualification of facilities and equipment used for GMP production of APIs for clinical studies. This includes close collaboration with scientists in the API Pilot production and your QA colleagues across functions. 

Furthermore, your responsibilities involve:

• Identifying and contributing to strengthening the compliance level of our production facilities, acting as a trusted consultant and applying a strong QA mindset
• Contributing to resolving ad-hoc questions and complexities related to GMP compliance
• Approving documentation for the qualification of facilities and equipment, as well as other supporting documents for the Pilot facilities. 
• Overseeing validation activities, handling deviations, managing change requests, overseeing cleaning, and providing QA presence in production 
• Evaluating requirements and setting the quality direction for the API Pilot production and related projects.

 
In our department, we are continuously improving the quality of work, and we are constantly optimising our methods and processes to increase simplicity across CMC QA and CMC Development and Scaling. 

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. 
 
Qualifications
To be successful in this role, we imagine you:  

• Hold a minimum of a bachelor’s in Pharmacy, Engineering, Biology, Chemistry, or a similar discipline
• Possess relevant experience in GMP and quality assurance within a highly regulated industry
• Have an understanding of the important aspects of regulations, requirements, and guidelines for pharmaceutical development and production 
• Showcase a well-developed understanding of quality and a natural urge to handle quality issues at the right level
• Display fluency in both spoken and written Danish and English 

It would be considered as a strong advantage if you have a good understanding of technical equipment used in a QA setting.  

On a personal level, 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 like working with many different stakeholders. You can work with many tasks at the same time and will make decisions and follow up on quality related problems. Further, it is key that you value being part of a top-performing team, were we use regular feedback and challenge each other to become even better.  
 
About the department   
CMC API QA is a department of skilled and motivated colleagues, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of 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 also have the responsibility of releasing API from contract manufacturers across the globe. 

Divided into four teams, you will be part of the Facility and Equipment team consisting of 10 QA professionals. The Team is responsible for assignments at the API pilot facilities assuring the quality of the facilities and the equipment.  
 
In the department, we value teamwork, diversity and humour very high, and we will make sure you, as our new employee, feel welcome and integrated. You will receive an individual training plan made by your mentor.  
 
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. 
 
Contact  
For further information, please contact Manager Kristian Goldeman Ernstsen at +45 34441459. 
 
Deadline  
16 April 2025.  
  
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. 

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