Senior Scientist, Inspection & Audit

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

At AGC Biologics, we are committed to a high standard of quality and execution - because we recognize that meeting the needs of our customers contributes to meeting the needs of providers and patients. As a global CDMO, the Inspection & Audit team plays a vital role in managing regulatory inspections, customer audits, and internal audits. Being part of this team as a Senior Scientist gives you a high visibility role with a significant scope and responsibility and direct exposure to global regulatory authorities and key customers. We offer you an opportunity to own and shape the internal audit program and inspection readiness strategy with room to grow and develop in our global and GMP-regulated environment.

We Are Building The Team With 2 New Colleagues! 

The Inspection & Audit team is part of the Quality Systems department and plays a central role in the Quality organization at AGC Biologics. The team is looking for two highly experienced Senior Scientists to join our team onsite in Søborg, just outside of Copenhagen. You will be joining a diverse team of two highly dedicated Senior Scientists and one Student with several years of experience within quality assurance. We enjoy being gathered for bi-weekly team meetings and GMP Grind sessions as well as breakfast on Thursdays and social activities!

We are actively involved in the continuous development and improvement of the quality system at our Søborg facility, with close collaboration across our global AGC sites. The team works cross-functionally to ensure quality-related activities are carried out effectively, efficiently, and in compliance with cGMP — with open communication, professionalism, and a genuine commitment to high-quality service at our core. 

We Are Taking Inspections & Audits To The Next Level 

As a  Senior Scientist, you will be a key contributor in managing regulatory inspections, customer audits, and internal audits. You will play an active role in driving inspection readiness, leading internal audit programs, and spearheading quality improvement initiatives across the site. The core of this position lies in your ability to lead inspection and audit activities with confidence and expertise, and to translate experience into tangible quality improvements. This is a senior role in every sense of the word — if you recognize yourself as someone who would like to showcase your internal audit and inspection toolbox and take the team to the next level, you may be exactly the colleague that we are looking for! Driving Inspections, Internal Audits and Customer Audits will be at the heart of what you do, alongside driving continuous improvement:

• First of all, we will trust you to be one of the driving forces of ensuring regulatory inspections and inspection