Manager Quality Management & GxP Compliance (m/f/d) bei Freseniusglobal
Freseniusglobal · Bad Homburg, Deutschland · Onsite
- Senior
- Optionales Büro in Bad Homburg
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)
Mindesteingruppierung/Minimum Grading:
