Leiter Qualitätsmanagement & GxP Compliance (m/w/d)

Your assignments

• Monitoring and securing GxP compliance according to internal policies and regulatory standards.




• Managing activities to maintain quality management system compliance, including document, change, and deviation management.




• Preparing, updating, and reviewing quality management documents such as SOPs, work instructions, guidance, and validation documents.




• Planning and conducting trainings on quality techniques and regulations (e.g. CSV, EU GMP).




• Having responsibility as Quality Manager for GxP-relevant computerized systems




• Validation of QM/RA processes in GxP-relevant computerized systems across the entire system life cycle (e.g. development of strategies, preparation of plans/reports).




• Coordinating periodic reviews of systems and processes.




• Participating as a GxP compliance expert in supplier audits and collaborating with Fresenius Kabi internal IT on GxP activities.

Your profile

• Completed studies in natural science (such as biochemistry, biology, pharmacy, mathematics) or engineering (such as biotechnology, medical technology)




• Minimum of three years of experience in a GxP regulated environment, especially in quality management




• Advanced expertise in validating GxP-relevant computerized systems




• Good knowledge of GAMP 5 and relevant regulations (e.g. 21 CFR Part 11 and EU GMP Annex 11)




• Familiarity with electronic systems used in Quality Management (QM) and Regulatory Affairs (RA)




• Experience with both traditional and agile project management methodologies as well as first experiences with AI in the GxP environment




• Excellent English language skills (spoken and written), along with experience working in virtual and multicultural teams




• Team-oriented with high quality awareness, confident communication, intercultural competence, solution-oriented and structured thinking, independence, organizational strength, and advanced software skills (MS Office, Visio, SharePoint, Trackwise, Documentum)

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