Senior Quality Assurance Professional for CAPEX projects

Are you an experienced Quality Professional with in-depth knowledge of QA standards, GMP requirements, and production environments? Would you like to make impact by assuring the highest quality standards at our state-of-the-art manufacturing facilities? 

Novo Nordisk is establishing new, ground-breaking facilities utilizing modern technology with automated operations and digitalized processes, for future oral and injectable production of Active Pharmaceutical Ingredients (API). 

Join our dynamic and engaging API Expansions QA Project & IT team and make a difference by upholding quality standards, ensuring patient safety, and developing future technologies. Explore this exciting opportunity with us and apply for a life-changing career today! 

The position 

You will play a pivotal role in ensuring the right level of compliance in projects redesigning existing facilities and building brand new manufacturing plants for the future. Working on Major Capex Projects, your role will be instrumental in: 

• Working across the PS API organization with expansion projects for API production. 
• Playing a key role in system design, quality risk management, supplier management, and equipment qualification and validation activities. 
• Finding solutions that integrate quality and compliance within the organization. 
• Working in close collaboration with highly motivated and specialized colleagues and stakeholders. 
• Being involved in all phases of expansion projects such as design, construction, qualification, and validation, assuring stable and robust processes. 

Qualifications 

We are looking for someone with: 

• A BSc or MSc degree in a Life-science, Pharmacy, Biology, Engineering, or a similar discipline. 
• Extensive experience from the pharmaceutical industry (5+ years), preferably within quality for project execution, supplier management, qualification, and validation. 
• Quality and/or API manufacturing background. 
• In-depth knowledge of QA routines, GMP requirements, and production environments. 

On a personal level, you enjoy close teamwork, are a strong motivator of others, and are able to maintain an overview when things are difficult. 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. Full English proficiency and strong communication skills are required. Knowledge of Danish will be beneficial. 

About the department 

At API Expansions QA Project & IT we work to ensure involvement in CAPEX projects aiming to establish compliant and timely approved facilities and setting the foundation for flawless operation of our new manufacturing plants. We collaborate with API production areas, internal and external stakeholders both in DK and international. We highly value open communication and strong collaboration among our team. Social responsibility is a priority in the department – it must be fun and challenging to go to work.  

Working at Novo Nordisk 

At Novo Nordisk, we don’t wait for change. We drive it. Join us on our journey into the future and make your mark on a newly established organization that will be growing in the coming years. Join us if you would like to work with dedicated and experienced QAs for biotech professionals, if you are curious about the opportunity to establish a factory that bridges new and automated technologies with strong know-how and expertise in biotech manufacturing; and if you are interested in starting up the new facility and when built become part of the team supporting production of the new products.  

Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Together, we’re life changing! 

Contact 

For further information, please contact QA manager: Siv Degn on phone +45 30752692. 

Deadline 

16 March 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. 

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.