Manager Quality Management & GxP Compliance (m/f/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)