Senior Scientist, Inspection & Audit

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 readiness. You will be preparing the organization for regulatory inspections (e.g. DMA, FDA, ANVISA, MFDS) ensuring compliance with applicable regulations and standards, as well as driving inspection readiness activities, e.g. compliance risk assessments, presenter preparation, logistical infrastructure, and staff training.
• Secondly, you will be acting as Lead Internal Auditor. You will be planning, leading, and executing internal audits across site functions, identifying compliance gaps and systemic issues and driving timely and effective resolution. Also, we will encourage you to continuously improve the internal audit program, e.g. scheduling, execution, follow-up, and effectiveness of verification. 
• Finally, you will be trusted to manage all aspects of customer audits, from pre-audit preparation through to post-audit follow-up and CAPA management, providing guidance to SMEs on addressing observations effectively before submission. Further, you will facilitate, negotiate, and maintain Quality Assurance Agreements (QAAs) with customers, ensuring alignment with regulatory requirements and internal quality standards, and driving timely reviews and updates.
• Overall, taking the Inspection & Audit team to the next level requires a commitment to continuous improvement. You will analyze trends to identify systemic issues, lead cross-functional corrective and preventive actions, and communicate regularly with senior management on outcomes, risks, and opportunities.

We Are Looking For An Experienced Internal Auditor From A GMP-Environment 

You will be joining a highly skilled team who values your scientific knowledge and insights, so bringing a master's degree in pharmacy, biochemistry, or a related life sciences field gives you the ideal foundation. In order to conduct the above-mentioned audits, you must have experience from internal audits or as an internal lead auditor in a GMP-regulated environment of the pharmaceutical, biotech, or medical device industry. This set of competencies typically translates into a minimum of +5 years of experience.  

Further, it is an advantage if you bring solid knowledge of regulatory standards (e.g. EU GMP, 21 CFR, ICH), and proven experience in inspection readiness, coaching SMEs through audit observations, and the ability to communicate and negotiate confidently and clearly with senior management, regulatory authorities, and customers, supported by proficiency in QMS and audit management tools. We know that this requires a key set of personal characteristics, like diplomacy, integrity, critical thinking, attention to detail, and the ability to influence and collaborate across functions. Finally, we highly appreciate if you bring experience with Front Office and/or Back Office roles during regulatory inspections, facilitating and managing QAAs and driving quality improvement initiatives.

Would You Like To Make An Impact On The Inspections & Audits Of Our Global CDMO? 

We hope that this opportunity has caught your eye and interest! If so, apply today and no later than April 19. Please submit your CV including a short motivation at the top about what impact you are motivated to make on this team and across AGC Biologics. If you have any Lead Auditor Certificates or similar relevant documentation, please attach it when you apply. We will review applications on a continuous basis and expect to conduct the interview process during April and May, with first round interviews in week 18 and second round interviews in week 19. We aim for a start date as soon as possible. If you have any questions before you apply, you are welcome to contact the Manager, Joanna Sadiq, on jsadiq@agcbio.com. We are looking forward to hearing from you!