Manager, Facility Compliance & Qualification – Lead Quality Where Patients Depend on It

AGC Biologics A/S; København; On-site; DKK 1,200,000 - 1,800,000; Full time

Job summary

AGC Biologics A/S in Copenhagen leads a team focused on facility compliance and qualification to sustain GMP-ready environments, clean utilities, and cleanrooms across our Søborg facilities. You will supervise investigators and qualification experts, ensuring adherence to regulatory expectations while driving continuous improvement.

The role requires a strong engineering background, extensive GxP knowledge, and proven leadership skills to guide cross-functional teams across Engineering,

Qualifications

• Minimum 5 years of experience as a manager in a relevant field.
• Experience working with high quality standards and GxP regulations.
• Academic background in engineering, biotechnology, biology, chemistry or similar.
• Excellent collaboration skills and ability to motivate others.
• Strong sense of urgency, problem solving and obstacle removal.

Responsibilities

• Lead, coach, and develop a high-performing team of investigators and qualification experts.
• Set direction, priorities, workload and maintain team motivation.
• Oversee quality processes for clean utilities (HVAC, WFI, HPW, gases) and clean room requirements.
• Manage Deviations, CAPAs, Changes and Qualification activities.
• Build audits and inspection readiness; ensure regulatory updates are addressed.

Skills

Team leadership

Collaboration

Communication

GxP regulations

Engineering background

Education

Engineering/biotech degree

Job description

Would you like to help secure the quality of our production facilities in Copenhagen, where the purpose is to bring hope to life by enabling life-changing therapies for patients around the globe? As our next Manager, Facility Compliance & Qualification, you will lead the team responsible for ensuring that our facilities, clean utilities and cleanroom environments continue to meet the highest GMP standards. Your leadership will help create the foundation that enables life-changing medicines to reach patients safely and reliably. If you are passionate about people leadership, thrive in a regulated environment and enjoy driving quality, collaboration and continuous improvement, this could be the opportunity for you.

Lead a team that enables operational excellence

The Facility Compliance & Qualification team is part of Facility Management within Engineering and supports our manufacturing facilities in Søborg, Copenhagen. In this role, you will lead a team of investigators and qualification experts responsible for maintaining compliance across qualified utility systems and cleanroom environments. Working closely with colleagues across Engineering, Manufacturing and Quality, you will help ensure that our facilities remain inspection-ready while continuously improving the way we work.

Your main responsibilities

• Lead, coach, and develop a high-performing team of investigators and qualification experts
• Set direction and priorities, manage workload and have focus on team motivation
• Oversee and manage the quality processes and procedures within the area of clean utilities (HVAC, WFI, HPW, Gasses and other qualified utility systems)
• Oversee and manage the quality processes of clean room requirements (gowning, aseptic behavior, pest control and cleaning, CCTV and access control)
• Manage the handling of Deviations, CAPAs, Changes and Qualification activities
• Build audits and inspection readiness
• Follow up on regulatory updates and ensuring assessment gaps and necessary actions to meet requirements (i.e., EU GMP, 21 CFR and ICH guideline)
• Lead a GEMBA culture for compliance check and verification of processes
• Drive Lean leadership and encourage continuous improvement
• Ensure close collaboration with internal and external stakeholders

What we are looking for

You have minimum 5 years of experience as a manager and experience as a professional within engineering.

You are used to working with high quality standards and consider you self an expert within GxP regulations.

It is a requirement for this position to have a relevant academic background within engineering, biotechnology, biology, chemistry or similar.

You are an excellent collaborator and can motivate others.

You operate with a strong sense of urgency, see solutions and remove obstacles.

You possess good communication skills - including the ability to communicate clearly and professionally in English and Danish both oral and written.

A team built on collaboration

At AGC Biologics, you will join a team characterized by knowledge sharing, high accountability and a pragmatic approach to solving complex GMP challenges. We believe the best solutions come from close collaboration, visible leadership and empowering people to take ownership. As a manager, you will have the opportunity to develop both people and processes while contributing to the continued success of one of Europe's leading biologics manufacturing sites.

Help bring hope to life

When you join AGC Biologics, your work has a direct impact on patients waiting for life-changing therapies. You will become part of a global organization that combines scientific innovation with a collaborative culture, offering opportunities to grow both professionally and personally.

Ready to make an impact?

31 August 2026

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life-changing advanced biologics for some of the world's most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market. AGC Biologics is Your Friendly CDMO Expert - dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world's most innovative pharmaceutical companies to develop and manufacture their life-changing drug products. If you're motivated by meaningful impact and ready to join our journey, we invite you to explore our current opportunities!