Senior Auditor / R&D Quality Manager (m/f/d) (ID: 22169)

Das ist der Job

We are searching intelligent and innovative employees.

Darum lohnt es sich

Develop and maintain risk-based audit plans and study assessment strategies Evaluate audit findings, ensure proper documentation, and support CAPA development and follow‑up Lead and manage quality escalations arising from clinical study activities Contribute to the development and maintenance of the Quality Management System, including SOPs, CAPA, deviations, and document control Provide quality consultation to Clinical Operations teams on study processes and quality–related topics Support qualification and evaluation of clinical service providers such as CROs, laboratories, couriers, and archiving services Deliver training on GCP, Good Clinical Laboratory Practice, and other quality-related topics Your profile University degree in a scientific or technical field such as Life Sciences, Pharmacy, or Medical Technology Several years of experience in Quality Management, Clinical Research, or auditing within a GxP/GCP-regulated environment Strong knowledge of regulatory requirements for medical devices and pharmaceuticals Proven experience in planning, conducting, and following up on internal and external audits Solid understanding of CAPA processes, dev If you are interested in working for a dynamic company with flat hierarchy, we look forward to receiving your application.

Responsibilities Plan and conduct clinical project audits, process audits, and supplier/vendor audits in accordance with GxP and regulatory requirements.