Your responsibilities

• Lead, build, and develop the operational QC team, including external supplier and contract laboratory oversight
• Manage and optimize claim handling, non-conformity management, CAPA processes, and root cause analyses (e.g., 8D, Root Cause Analysis)
• Ensure proper handling, storage, and traceability of materials throughout the supply chain
• Develop and implement strategies for continuous quality improvement both internally and with suppliers
• Coordinate audits, inspections, and regulatory reviews related to quality control and supplier management
• Maintain documentation integrity and compliance with IVDR, FDA QSR, cGMP, and GxP requirements
• Collaborate closely with Supply Chain, Regulatory Affairs, Manufacturing, and Quality Assurance departments to ensure integrated quality management
• Mentor and develop team members to promote a responsible and proactive quality culture

Our requirements

• Degree in Microbiology, Biological Sciences, Biotechnology, Pharmacy, or a related natural science or engineering field; PhD advantageous
• 5–10 years of professional experience in operational industrial companies, preferably in biotech, diagnostics, or medical devices
• Extensive experience in claim and complaint handling, non-conformity management, and improving quality processes along the supply chain
• Solid knowledge and practical experience with microbiological test methods and regulatory requirements (IVDR, FDA QSR, cGMP)
• Solid expertise in microbiological testing methods, including culture techniques, PCR, sterility testing, endotoxin assays, and environmental monitoring.
• Proven leadership skills and experience in building and managing QC teams and supplier quality control
• Strong problem-solving capabilities and experience with quality systems and continuous improvement methodologies
• Excellent English communication skills, spoken and written; German language skills are an advantage

What we offer

• Attractive salary

• Flexible working hours and remote work options

• Comprehensive training and professional development opportunities within a fast-growing, innovative company

• Modern, well-equipped workplace and a collegial team environment