Your assignments Business Process Ownership : a) Owns business process of specific global RA/Q- GxP computer system ( s ) within QM-Systems, Certification & Clinical Trials, ensuring regulatory compliance throughout the system lifecycle, including Gxp -compliant change management in exchange with key business stakeholders. b) Training & Deviation Handling: Conducts business process training, manages deviations and change control, and assesses global SOPs/WIs for implementation. c) System Lifecycle Management: Oversees implementation, operation, and decommissioning of computerized systems, including validation, risk analysis, and data integrity assurance. d) Documentation & Compliance Monitoring: Creates procedural documents (SOPs/WIs), documents quality deviations, supports periodic system reviews, and coordinates with IT department. Quality Management System (QMS) Maintenance: Development, review and update of QMS documents (e.g., GSOPs, GWIs) and supports internal and external audits as GxP SME. Project Management : Leads or supports projects under QM - Systems, Certification & Clinical Trials, including planning, coordination, documentation, and workshop facilitation. Pharmaceutical Evaluation & Classification: Acts as the departmental contact for evaluating and categorizing raw materials and medicinal products, with a focus on regulatory aspects. Regulatory Compliance Oversight: Ensures implementation and adherence to legal and regulatory requirements (e.g., AMG, AMWHV, GMP, ICH, ISO) for raw materials and drugs within Fresenius Kabi Deutschland GmbH. Subject Matter Expertise: Provides expert input on pharmaceutical and pharmacological matters, supports projects involving pharmaceutical substances (e.g., IDMP), and represents the company in regulatory forums (e.g., EMA, Medicines for Europe). Your profile University degree (at least diploma or master`s degree), preferred in pharmacy Several years of experience in a GMP-regulated environment, preferably GxP computerized system compliance in the field of Quality Management or Regulatory Affairs as well as in GxP -compliance of computerized system (validation) in pharmaceutical industry Good experience in change management according to GxP for business processes in electronic QMS (preferably Trackwise ) Experience in the harmonization of master data in accordance with authority regulations in pharmaceutical industry Very good knowle d g e in 21CFR Part 11, EU GMP Annex 11 and PIC/S PI 011-3 Proficient in English, both written and spoken Possesses strong teamworking abilities, effective communication skills, inter-cultural competence, and a high sense of quality and organization Demonstrates solution-oriented, structured thinking, adaptability in agile environments, and the ability to manage multiple tasks independently with confidence and decisiveness Mindesteingruppierung/Minimum Grading: E 10 (K)