Senior Manager Quality Management (m/f/d)

<h2>Your assignments</h2><ul><li><p>Independent planning and execution of audits in the GCP environment</p></li><li><p>Consulting for in-licensing projects regarding GCP requirements</p></li><li><p>Inspection preparation and risk assessment for clinical studies</p></li><li><p>QA activities including gap assessment for planned and ongoing GCP studies</p></li><li><p>Identification of critical data points in cooperation with the operational units</p></li><li><p>Risk-based auditing of the identified critical data points and audits of critical processes</p></li><li><p>Continuous research of new regulations, guidelines, and other regulatory changes in the GCP environment</p></li><li><p>Training of internal QA colleagues and stakeholders on regulations.</p></li><li><p>On-site auditing of high-risk studies, including biosimilar studies, in hospitals worldwide. </p></li><li><p>Qualification of GCP vendors for clinical needs.</p></li><li><p>Auditing computerized systems, IT vendors and advising colleagues on CS validation requirements.</p></li><li><p>Development and updating of applicable subject-specific SOPs</p></li><li><p>Preparation and Participation in regulatory inspections (EMA/FDA, etc.)</p></li></ul><p></p><h2>Responsibilities / Duties</h2><ul><li><p>Consulting in terms of study designs with Business Units at Fresenius Kabi</p></li><li><p>QA primary point of contact for high-risk studies, incl. Biosimilar studies</p></li><li><p>Preparation and conduct of GCP audits (e.g., document audits, CRO/vendor audits, site audits, process audit, system audits, audits of critical data points)</p></li><li><p>Compilation of audit report/audit action plan/audit closure memo</p></li><li><p>Tracking of Corrective and Preventive Actions</p></li><li><p>Preparation and support before, during and after Regulatory Inspections</p></li><li><p>Support of Sr. Director in consultancy when it comes to In-Licensing projects</p></li><li><p>Compilation and review of global SOPs/WIs, revising of QA SOPs/WIs in case of regulatory updates</p></li><li><p>Performing gap assessments to new <span>regulations/guidelines,</span> implementing actions to close gaps</p></li><li><p>Supervision of Working Students</p></li></ul><p></p><h2>Your profile</h2><ul><li><p>University degree in natural sciences</p></li><li><p>At least 10 years of professional experience in the field of quality assurance in clinical trials</p></li><li><p>Qualified GCP auditor (minimum experience in GCP auditing of at least 5 years)</p></li><li><p>Very good knowledge of relevant regulatory requirements, laws and guidelines</p></li><li><p>Very good knowledge of applicable SOPs in QM area</p></li><li><p>Very good knowledge of GCP relevant regulations</p></li><li><p>Very good knowledge in the field of computer system validation</p></li><li><p>Very good knowledge in the field of risk management in clinical trials</p></li><li><p>Very good prioritization skills, even in stressful situations, and willingness to make decisions as well as high motivation and self-initiative</p></li><li><p>Willingness to travel</p></li><li><p>Very good knowledge of English language both written and spoken</p></li></ul><p><span><span><span><span><span><span><span><span>Mindesteingruppierung/Minimum</span></span></span></span></span></span></span></span> Grading:</p>E12 (K)