Advise project teams and internal functions on quality and compliance requirements, including applicable GxP standards, international guidelines, and regulatory expectations
Plan, coordinate, and support internal and external audits and inspections, including preparation, execution, documentation, and follow-up of findings
Conduct risk analyses across processes and studies, assess quality and compliance risks, and derive appropriate improvement measures
Support CAPA management activities, including root cause analysis, definition of corrective and preventive actions, and effectiveness checks
Develop and deliver targeted quality training and support the creation, maintenance, and review of SOPs, work instructions, and other quality-relevant documentation

Scientific or medical degree, or comparable background, combined with several years of experience in quality management within clinical research or life sciences
Strong understanding of regulatory and quality requirements in clinical research, including GxP principles and end-to-end research processes
Experience with audits, inspections, risk management, and CAPA processes, with the ability to identify process dependencies and improvement opportunities
Fluent German and English language skills, both written and spoken, with willingness to travel nationally and internationally as needed

Opportunities for personal and professional growth in a rewarding environment
Team that values collaboration, quality, and making a difference in the lives of patients

Quality Manager

Key skills