GMP Facility Compliance Lead

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

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,