Your assignments Independent planning and execution of audits in the GCP environment Consulting for in-licensing projects regarding GCP requirements Inspection preparation and risk assessment for clinical studies QA activities including gap assessment for planned and ongoing GCP studies Identification of critical data points in cooperation with the operational units Risk-based auditing of the identified critical data points and audits of critical processes Continuous research of new regulations, guidelines, and other regulatory changes in the GCP environment Training of internal QA colleagues and stakeholders on regulations. On-site auditing of high-risk studies, including biosimilar studies, in hospitals worldwide. Qualification of GCP vendors for clinical needs. Auditing computerized systems, IT vendors and advising colleagues on CS validation requirements. Development and updating of applicable subject-specific SOPs Preparation and Participation in regulatory inspections (EMA/FDA, etc.) Responsibilities / Duties Consulting in terms of study designs with Business Units at Fresenius Kabi QA primary point of contact for high-risk studies, incl. Biosimilar studies Preparation and conduct of GCP audits (e.g., document audits, CRO/vendor audits, site audits, process audit, system audits, audits of critical data points) Compilation of audit report/audit action plan/audit closure memo Tracking of Corrective and Preventive Actions Preparation and support before, during and after Regulatory Inspections Support of Sr. Director in consultancy when it comes to In-Licensing projects Compilation and review of global SOPs/WIs, revising of QA SOPs/WIs in case of regulatory updates Performing gap assessments to new regulations/guidelines, implementing actions to close gaps Supervision of Working Students Your profile University degree in natural sciences At least 10 years of professional experience in the field of quality assurance in clinical trials Qualified GCP auditor (minimum experience in GCP auditing of at least 5 years) Very good knowledge of relevant regulatory requirements, laws and guidelines Very good knowledge of applicable SOPs in QM area Very good knowledge of GCP relevant regulations Very good knowledge in the field of computer system validation Very good knowledge in the field of risk management in clinical trials Very good prioritization skills, even in stressful situations, and willingness to make decisions as well as high motivation and self-initiative Willingness to travel Very good knowledge of English language both written and spoken Mindesteingruppierung/Minimum Grading: E12 (K)