Outsourcing QA Coordinator

Are you passionate about working with coordination across and out of a high performing Quality organisation? We are looking for a new Outsourcing QA Coordinator to join our department. 

The position 

In this position you will work closely with our Qualified Persons, Auditors and colleagues working with outsourcing activities from a Q perspective. 

We are currently increasing our use of  contract acceptors due to the success of our development programs. To ensure continuous compliance with regulatory expectations, you will therefore:

• Maintain IMP (Investigational Medicinal Products) list of Contract Acceptors used by our stakeholders ensuring overview, compliance and inspection preparedness. 
• Work closely with QP’s and QA Outsourcing Managers within administrative tasks regarding selection, approvals and maintenance of new Contract Acceptors. 

Our audit activities are growing. We need to have efficient and effective coordination within our local organization and across NN for this activity. You will therefore:

• Coordinate external audits at Contract Acceptors within the CMCQA.  
• Collaborate with other audit functions within NN where we share Contract Acceptors. 

As a support department we experience that new tasks are coming our way in a continuously evolving landscape within NN. You can therefore expect your portfolio of tasks to develop wherefore the job and the need for skills will be changing with the business needs.  

Qualifications 

To be successful in this role, we expect you to have:  

• A technical/manufacturing background or experience within the GMP regulated industry. It could be you are straight out of pharma school with a flair for administration or you are long time experienced coordinator with administrative background. 
• Preference for coordinating and working across an organization – and preferably some knowledge of outsourcing in the pharmaceutical industry. 
• Strong stakeholder management skills and the ability to communicate on all levels of the organization. 
• A preference for working independently and be ready to grow to you full potential.
• High proficiency in both English and Danish. 

On a personal level you are proactive with a curious and pragmatic approach. You will be able to build strong relations to have solid cooperation across the different areas. You thrive in an environment with many stakeholders where you need to navigate at all levels in the organization. 

About the department 

You will be joining a small department of 6 employees, whose main responsibility is to support CMC QA with a variety of tasks. The 6 of us are specialized in different areas and tasks. We do however take pride in supporting each other to solve tasks across CMC QA. A true support department. 

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 

For further information please contact Director Birthe Boldig Rottwitt, 30750158. 

Deadline 

22 November 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 resume or CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.  

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.