Quality Assurance Manager / Auditor | Biologe (m/w/d)
SocraTec R&D Concepts in Drug Research and Development GmbH
Job Summary
This role is centered on maintaining and advancing the Quality Management System (QMS) for a specialized clinical research organization (CRO) cluster. Operating out of Oberursel, you will be responsible for the quality assurance of clinical trials in accordance with GCP and GVP standards. Day-to-day activities include reviewing qualification and validation documents for computerized systems, managing deviation and change control processes, and conducting independent internal and subcontractor audits. You will also play a key role in tracking CAPAs and preparing for external inspections and client audits. This position is unique because it offers the opportunity to work across two closely linked companies specializing in early-phase research and biometrics, providing a comprehensive view of the clinical development lifecycle. It is an ideal environment for those who value structured, solution-oriented work within a collaborative, innovative team that bridges the gap between boutique service and multinational study capabilities.
Required Skills
Education
University degree in Natural Sciences (e.g., Biology), Pharmacy, Healthcare Quality Management, or a comparable qualification.
Experience
- Professional experience in clinical research or quality management is preferred.
- Experience in deviation management, change control, and document control is ideal.
- Experience in conducting or supporting audits and regulatory inspections.
- Open to dedicated entry-level professionals with a strong scientific background.
Languages
Additional
- Location: Oberursel; Full-time availability required; Ability to conduct independent audits and travel for subcontractor assessments.
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