Quality Manager
TFS HealthScience - Contract Research Organization
full-time
Posted on:
Location Type: Hybrid
Location: Frankfurt • Germany
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About the role
- 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
Requirements
- 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
Benefits
- Opportunities for personal and professional growth in a rewarding environment
- Team that values collaboration, quality, and making a difference in the lives of patients
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality managementrisk analysisCAPA managementroot cause analysisSOP developmentauditsinspectionsregulatory complianceGxP standardsclinical research
Soft Skills
communicationorganizational skillsproblem-solvingattention to detailteam collaborationtraining deliveryanalytical thinkingadaptabilityinterpersonal skillsleadership