Experienced QA Professional for Validation and Automation/IT

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Are you ready to play a key role in building a new groundbreaking biotech Active Pharmaceutical Ingredients (API) production facility? As a QA Professional at Novo Nordisk, you’ll lead quality assurance efforts during the design and construction phases, ensuring compliance and setting quality standards. Can you handle complex quality issues and drive best-in-class solutions? Join us in shaping the future of pharmaceutical innovation, apply now! 

The position 
In this role, you will be part of a highly skilled QA team allocated to perform quality assurance activities during design and construction of the new API production facility in Hillerød. The QA team will support the project throughout the project phases of the facility, hereby securing quality oversight and setting the direction for implementation of cGMP. As a QA Professional, you will be part of a fantastic QA team and you will be reporting to an Associate QA Manager. 
 

Your main responsibilities will be to:

• Setting the quality direction for the project within automation and IT
• Deliver best in class quality oversight and approval for automation and IT validation activities
• Handle larger and complex quality issues and act as sparring partner regarding quality matters for your stakeholders
• Communicate and explain the internal and external requirements such as EU GMP and GAMP5 for the project team members and relevant project stakeholders to achieve high level compliance
• Promote and support a strong quality culture in close collaboration with our stakeholders in the project team

We are seeking the right candidate to join our team and will place them in a job level that aligns with their experience and skills. We encourage professionals at all levels—whether junior or senior to apply.
 

Qualifications 
To succeed in this role, you have: 

• An academic degree within automation, IT, science or another relevant field
• Some years’ experience within validation/qualification of IT, automation and/or equipment
• Gained said experience from the pharmaceutical or medical devices industry
• Knowledge of GMP requirements for Active Pharmaceutical Ingredients production 
• Full English proficiency 

It would be seen as an advantage if you have experience with DCS and MES systems, IT infrastructure and software.
 

On a personal level, you enjoy close teamwork, are a strong motivator of others and can stay balanced, when the waves get high. You demonstrate great communication skills and are able to clearly and precisely communicate complex matters to stakeholders, thriving a multicultural environment working across organizational borders and management levels. 

Building structures comes naturally to you and you enjoy simplifying wherever simplicity can benefit reaching the goals fast and in a sound and solid manner. 

Are you not quite fulfilling the above qualifications but still think you’re a good match for the position for other reasons? Don’t hesitate to apply and tell us why. 

About the department

API Expansions QA 25L is a department with 15 motivated colleagues with experience ranging from lesser experienced to expert, all based in Hillerød. Our focus is to ensure compliance, timely approval and the foundation for flawless operation of our new facilities while making our department the best place to work. We enjoy having a good laugh together and emphasizes psychological safety as well as continuous individual improvement. We are a multicultural team and our daily spoken and written language is English. 

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 

If you require further information, please contact Associate Manager Emma Grund Secher on phone +45 34440721

Deadline

31 January 2025

You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to apply in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 

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