Would you like a central role in a dynamic department with tasks that involve close collaboration with many stakeholders on a daily basis? Do you have experience with inspections and authority interactions, and a solid understanding of good manufacturing practice? Are you passionate about compliance, structure, and continuous improvements? Are you self-motivated, structured and have an efficient nature, and do you can see solutions in a broader perspective?

If yes, you might be exactly the one we are looking for to join our team. Apply today!

The Position
You will be part of the Purification plant V (PPV) project to establish a super-sized purification facility for manufacturing of biological APIs in Kalundborg. Your role will be responsible for our setup for audits and inspections, and we need your expertise and experience to set direction and start-up this important part of our operational readiness. We are looking for a quality coordinator who knows this role well and can drive and establish our audit and inspection setup within PPV. While we are in the project phase your role will be to establish our audit and inspection set-up and to coordinate and execute on the audit plan as well as prepare the organization for future audit and inspections. In addition, you will contribute to developing our project quality documentation. When we are in operation, it will your role to maintain the audit setup and secure efficient follow-up on any actions. In addition to this, you will have the opportunity to collaborate with other quality coordinators in PPV and PS API to handle exciting tasks across the area, e.g. focusing on improving performance on quality KPI’s.

Your role will be to:
• Establish the setup for audit and inspection in PPV.
• Plan audits and inspections including coordination with internal audit and inspection coordinators.
• Train organization in audit and inspections.
• Drive preparation for and follow-up on authority inspections and internal audits.
• Support the project in quality task (cGMP) together with the quality expert team.
• Support and prepare deviations and help in setting up quality KPIs in PPV

Qualifications
To be considered for this position you must have:

• An academic degree (BSc or MSc) in natural science, engineering or similar.
• Preferably +1 years of experience from similar position within Novo Nordisk.
• You are familiar with complex quality processes and have experience from Good Manufacturing Practice (GMP) regulated areas.
• Experience with ISO and/or LEAN is an advantage, as it is an integral part of our everyday work.
• Full proficiency in English.
On a personal level you thrive and get motivated by working with and across multiple levels in the organization, whilst you are known for your excellent collaboration and communication skills and ability to set direction. You are solution oriented and work systematically, proactively and strive for simplicity in processes, while taking pride in solving your tasks and challenges as close to the process as possible, with close involvement of your stakeholders.
About the Department
We are expanding to increase production of Novo Nordisk’s current and future oral and injectable products by establishing a new and ground-breaking biotech facilities in Kalundborg. We embrace new technologies and we’re building a purification factory with a strong focus on digitalisation, automation, and robotics. All teams will continue to expand over the coming years. You will be collaborating closely with colleagues with backgrounds in chemistry, engineering, project management, automation and facility planning.

We know that a diverse group of people, delivers the best results, and we are eager to build teams where collaboration across professional backgrounds ensures a right first-time execution of highly complex projects. You will play a vital role in building and maintaining a healthy and inspiring work culture and have an abundance of opportunities for professional and personal development. Join Novo Nordisk Manufacturing in Kalundborg in times of expansion
Join us in the early stage of our journey and make your mark on a newly established organisation that will be growing in the coming years. If you want to work with dedicated and experienced biotech manufacturing professionals and are eager to take part in establishing a factory that bridges new and automated technologies with strong know-how and expertise in biotech manufacturing, then apply to join our team.

Today, 3,200 employees of Novo Nordisk Kalundborg produce half of the world’s insulin and a number of biopharmaceutical products. With more than 50 years of expertise in large-scale biotech manufacturing, we are today the world’s largest insulin-producing facility. By joining Novo Nordisk Manufacturing in Kalundborg, we promise you a developing career, where you will be met with trust and responsibility by dedicated colleagues with diverse backgrounds in a successful company with a higher purpose and an inclusive environment. Together, we make a difference every day for more than 30 million people living with diabetes and other chronic diseases. Contact If you would like to know more about the position, please contact Associate Manager, Karina Bjerg Bech, on +45 34487978
Deadline 29 February 2024. But we are reviewing candidates on an ongoing basis, and we will close the selection process once we have the right candidate. 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.