Senior QA Professional - Environmental Monitoring & Facility

Are you ready to play a key role in building a groundbreaking biotech Active Pharma-ceutical Ingredients (API) production facility? Motivated by the idea of leading quality assurance efforts during the design, construction and qualification phases, ensuring compliance and setting quality standards? Can you handle complex quality issues and drive best-in-class solutions? 

If yes, 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. There-fore, we are establishing a new, ground-breaking biotech API production facility in Hillerød.  

Your main responsibilities will be to:

• Set the quality direction for the project
• Deliver best in class quality for qualification/validation of facility and environ-mental monitoring
• Handle larger and complex quality issues
• Communicate and explain the internal and external requirements for the pro-ject team members and relevant stakeholders to achieve high level compliance
• Promote and support a strong quality culture in close collaboration with our stakeholders in the project team

In this role, you will be part of a highly skilled QA team allocated to perform QA activi-ties during design and construction of the new API facility, supporting the project throughout the various phases, securing quality oversight and setting the direction for implementation of GMP. 

Qualifications 
We are looking for a colleague with a robust skillset and experience within QA or pro-duction roles.

To succeed in this role, you have: 

• A Master’s degree within science or equivalent 
• Extensive experience from the pharmaceutical industry 
• In depth experience within validation/qualification
• Knowledge of GMP requirements for API production 
• Full English proficiency 

It will be seen as an advantage if you have experience and knowledge of facility and/or environmental monitoring.

On a personal level, you enjoy close teamwork, are a strong motivator of others and can stay balanced, even when the waves get high. You demonstrate great communi-cation skills and can clearly and precisely communicate complex matters to stakehold-ers, also to explain the intent of the GMP requirements for the project team members and relevant project stakeholders.

Finally, you thrive in a multicultural environment working across organizational bor-ders and management levels, building structures comes naturally to you and you en-joy 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 highly skilled and motivated col-leagues all based in Hillerød. Our focus is to ensure early involvement in the produc-tion facility investment projects to ensure compliance, timely approval and the foun-dation for flawless operation of our new facility.

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
28 November 2024

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.