Inspection Coordinator in Emerging Technologies QA

Category:

Quality

Would you like to play an essential role in facilitating inspections within the Emerging Technologies (ET) area at Novo Nordisk? Do you want to be a trusted and reliable partner, competently guiding both the inspectors and internal specialists through inspections in an efficient manner?

If yes, then we have this opportunity for you. Read more below and apply today for a life-changing career!

The position
As inspection coordinator you will be coordinating, supporting, and managing the inspections in Emerging Technologies in DK in close cooperation with QMS coordinators and Line of Business managers. It entails organizing the inspections and ensuring that everything is ready when the inspectors arrive, which means you have to coordinate getting the documentation for the inspectors beforehand and running the inspection back-office during the inspection.

This role requires an approachable and dynamic individual who can support the organization and Inspection team when inspected by external authorities, including pre-approval inspections, renewals, post-change inspections, paper-inspections, and routine inspections.

You will be required to understand our ET area and processes thoroughly, and you need to develop strong relations with contributing internal stakeholders, e.g., GMP-coordinators, specialists, and leaders. You will work closely with one dedicated and highly competent colleague (having responsibility for audits).

Your main responsibilities will include:
• Clarifying scope and timeline of inspections
• Arranging for meetings e.g. for planning, follow up and status
• Coordinating the collection of documents prior to an inspection and for paper inspections
• Managing the back office during inspection and ensuring a good flow of documents in and out of the inspection room
• Coordinating the distribution of observations and following up on status
• Conducting inspection trainings and ensuring a high degree of inspection readiness in ET
• Being a part of Novo Nordisk inspection network and supporting on continuous improvements of the processes

Our department is scheduled to move to new office buildings in Taastrup in September 2024.

Qualifications
We imagine the perfect candidate to have a strong background in Quality and are highly familiar with inspections from authorities within the pharmaceutical or medical device industry. You have knowledge in the development of worldwide industry regulations and inspection trends.

To excel in this role, you:
• Hold a master’s degree in life sciences or another relevant field
• Have strong experience in Quality Assurance within Pharmaceuticals or Medical Devices or strong experience as GMP coordinator
• Possess strong experience in coordination and stakeholder management
• Excellent communication and collaboration skills

• Experience with audits and inspections

• Are fluent in Danish and English

As a person, you are open minded with an outgoing attitude, able to set direction and inspire your colleagues. Your way of working is structured, and you have a high degree of independence.

About the department
Emerging Technologies QA is an area of three departments, where you will support the two Danish departments of approximately 80 skilled and motivated colleagues. We work with assuring quality and compliance of the facilities, the equipment, QC lab, manufacturing development, as well the as release of tablets for the market. We are proud to work in a fast-growing and ambitious part of Novo Nordisk.

You will be part of the Quality Support team which provides support across the department within different areas such as training and project management.

Working at Nono 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
For further information, please contact Kristine Boysen Pallesen at +45 34 48 18 24

Deadline
4 April 2024

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 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.