Are you ready to play a key role in building a groundbreaking biotech Active Pharmaceutical Ingredients (API) production facility? Do you aspire to lead quality assurance efforts during the design, construction, and qualification phases, ensuring compliance and setting quality standards?

If you are eager to handle complex quality issues and drive best-in-class solutions for a large project at Novo Nordisk, join us in shaping the future of pharmaceutical innovation! Apply now!

 

The position 
In Novo Nordisk we drive our business to the benefit of patients. To be able to bring new innovative treatments to patients worldwide, we are expanding our capacities to support the company portfolio of future oral and injectable pharmaceuticals. Therefore, we are establishing a new, groundbreaking biotech API production facility in Hillerød.  

As Senior QA Professional, 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 various project phases of the facility, securing quality oversight and setting the direction for implementation of GMP. 

Your main activities include:

Setting the quality direction for the project, handling large and complex quality issues Ensuring best in-class quality for the qualification of CIP/SIP systems, autoclaves, utensil washers, and cleaning validation (clean and dirty hold time)  Reviewing and approving protocols, reports, validation deviations, and cleaning procedures  Communicating and explaining the internal and external requirements for your QA colleagues and relevant project stakeholders to achieve high level compliance Promoting and supporting a strong quality culture in close collaboration with our stakeholders in the project team

You will be working with equipment cleaning and playing a critical role in ensuring the quality and safety of our future pharmaceutical products. You will amongst other tasks have the responsibility of ensuring that robust cleaning recipes are developed, and that cleaning processes are validated to meet regulatory requirements and industrial best practice.

Knowledge of equipment qualification, knowledge of general cGMP requirements and the ability to perform quality oversight according to GMP are essential skills in the job. You should be able to communicate and explain the intent of the GMP requirements for the project team members and relevant project stakeholders. 

 

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

Hold a master’s degree within pharmacy, manufacturing, engineering, chemistry, or another relevant field Bring relevant experience within validation/qualification, preferably from the pharmaceutical industry or another highly regulated sector Showcase solid knowledge of GMP requirements, ideally of API  Possess strong communication and collaboration skills Demonstrate full proficiency in both spoken and written English

It would be considered as a strong advantage if you have knowledge of equipment cleaning.

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 can clearly and precisely communicate complex matters to stakeholders. You thrive in 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. 

 

About the department
API Expansions QA 25L is a department with 15 motivated colleagues with diverse levels of experience, 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 emphasize psychological safety as well as continuous personal and professional improvement. You will be part of a multicultural QA team reporting to an Associate QA Manager.

 

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 at +45 34440721.

 

Deadline
2 March 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. 

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.