At Axolabs you work in an international team that is making groundbreaking progress in the development of nucleic acid-based drugs – from computer-aided drug discovery and high-throughput screening to large-scale manufacturing.

Our interdisciplinary teams combine expertise in oligonucleotide chemistry, bioinformatics, molecular biology, process engineering, analytics, and regulatory support. Whether you work as a scientist ,  technician, data expert, or in operations, your work contributes to improving the health of people worldwide. With locations in Petaluma (USA), Kulmbach, and Berlin (Germany), and as part of the LGC Group, we offer you a global, collaborative environment as a CRO and CDMO.

Job description

Actively shape quality from the very beginning. With us, you'll help build a new site complete with a GMP-compliant quality management system. As a team leader, you'll guide a motivated, small team and help cultivate an open, modern quality culture. Become part of our mission: "Science for a safer world ! "

Your tasks

• Ensure compliance with national and international GMP requirements and continuous improvement of the QMS.
• Coordinate QMS document control, including QA reviews, change, deviation, and CAPA processes.
• Plan and conduct internal and external audits and inspections, and consistently implement measures.
• Assess quality risks, qualify suppliers, and ensure sustainable complaint management.
• Lead and develop a small QA team and advise and train the specialist departments.
• Analyze and optimize KPIs, processes and procedures to continuously strengthen our quality culture.

Qualifications

That's what we want.

• Completed scientific studies in the field of biology, chemistry, biotechnology, pharmacy or comparable biomedical training
• Several years of experience in GMP-compliant quality management in the pharmaceutical industry
• Professional and disciplinary leadership experience and a passion for developing teams
• Proficient use of Office programs, very good German and English skills
• Ideally, knowledge of pharmaceutical manufacturing and analytical methods.
• Commitment, team spirit, strong communication skills and a sense of responsibility