Senior QA Professional for Validation and IT (Denmark, Hillerød)

Jobbeskrivelse
Placering
Hillerød, Denmark

Jobkategori
Quality

Ansøg nu

xx

Are you ready to play a key role in building a groundbreaking biotech Active Pharmaceutical Ingredients (API) production facility? As a Senior 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 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, ground-breaking biotech API production facility in Hillerød.

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 Senior QA Professional, you will be part of a QA team reporting to a Senior QA Manager.

Your main responsibilities will be to:
• Setting the quality direction for the project
• Deliver best in class quality for qualification/validation of equipment and IT-systems
• Handle larger and complex quality issues
• Communicate and explain the internal and external requirements such as EU GMP, 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

Qualifications
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 and IT
• Knowledge of GMP requirements for API production
• Full English proficiency

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.

About the department
API Expansions QA 25L is a department with 15 highly skilled and motivated colleagues all based in Hillerød. Our focus is to ensure early involvement in the production facility investment projects, in order to ensure compliance, timely approval and the foundation for flawless operation of our new facilities.

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 Jakob Lysgaard Krog on phone +45 30750534

Deadline
7 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.

xx