Advanced QA Professional for Finished Product

Are you thrilled about working with modern technology and like to push the boundaries of process performance and production technology? Does close international collaboration and networking across boundaries come naturally for you? 

Then you might be the QA professional we are looking for to support the establishment of our new production facilities across the world, who will play a key role in the future of production in Novo Nordisk. 

The Position
As QA Professional in Fill & Finish Expansions (FFEx) Quality you will help steer quality assurance operations when implementing new production lines in our global network. 

Your main responsibilities will include: 
• Supporting and developing global operational readiness procedures, ensuring a fast and sufficient ramp-up of our new facilities worldwide, specifically targeted to our Finished Product (FP) production- hence Assembly, Packaging and Warehouse.
• Ensuring compliance with internal and external quality requirements and regulatory requirements (GMP)
• Being part of creating, developing, and challenging the overall programme plan to ensure efficient and transparent systems, structures, and processes
• Support setting the scene for the quality mindset in the programme 
• Aligning with other areas within FFEx to ensure clear interface and roles

You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success. Our department is relatively new, therefore, there may be adjustments in its scope over time, providing opportunities for your growth and development within our organization.

This job is performed in an international environment so flexibility to travel is to some extent required.

Qualifications
We are looking for someone with a risk-based approach and the ability to balance compliance and product quality, a result-oriented person with a strong quality mindset.

To succeed in this role, you have:
• Bachelor’s or Master’s degree in Engineering, Chemistry, Pharmacy or similar 
• Preferably +3 years of experience in a QA role in the pharmaceutical industry within FP processes
• GMP knowledge
• Experience with QA operations e.g., batch release, deviations handling
• Full proficiency in English
 

We would also love for you to have knowledge of IT/OT and digitalisation.
As a person you are a team player, organized and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirit high even when under pressure and are a skilled communicator who can cooperate at any organizational level. 

About the Department
You will be joining FFEx Quality, an area anchored in Product Supply, Quality & IT (PSQIT), which globally employ approximately 25,000 of Novo Nordisk’s 65,000 employees.

It’s a newly established and growing area with the responsibility to design, plan and build all major FFEx projects across PSQIT to serve the needs of millions of patients, by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the facilities of the future, which we will still be proud of 20 years from now.

Our department is responsible for operational readiness from a quality assurance and compliance point of view, and for QA validation and qualification support for QC in the new facilities.