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

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 will include: 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'll 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'll 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'll 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? Please submit your application no later than 31 August 2026. Please note that we only accept applications submitted through our online recruitment system. Applications sent by email cannot be considered. We review applications on an ongoing basis and look forward to receiving your application. 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.