Head of Quality Assurance Clinical Research / Sponsor Quality Management in OWL (m/f/d)

Technical and organisational management of the quality assurance unit (QSE) of the university sponsor for clinical studies Expansion and maintenance of sponsor quality management and sponsorship SOP management Coordination and evaluation of applications to take over university sponsorship role for investigator-initiated clinical studies (IITs) Further development of risk assessments, Vendorqualification and sponsor Oversight Consultation and support of examiners, examiners and study centres in quality and GxP questions Examination of sponsor-relevant documents such as test plans, SOPs, monitoring concepts and risk assessments Planning, implementation and follow-up of internal and external audits Preparation, monitoring and follow-up of administrative inspections Creation of quality reports, audit plans and coordination of CAPA measures and Serious Breaches Conception and implementation of quality assurance training in clinical research Computer System Validation Support (GAMP5)

Complete university studies (state exams, degree (uni) or master) of human medicine or any other relevant scientific or health studies Multiannual professional experience in risk-based quality management in clinical research (QMS, CAPA, risk management), ideally also in university or academic environment Wide experience in the planning, organisation, financing and project management of investigator-initiated clinical trials (IITs) Knowledge of relevant regulations and guidelines (including ICH-GCP, EU-CTR, AMG and MDR/MPDG) Experience in regulatory advice on study-specific issues Experience in the planning and implementation of audits and accompanying inspections Very good knowledge of German and English in word and writing

Unlimited full-time permanent employment Attractive remuneration according to qualification and experience High design space in the construction and further development of a central quality assurance unit Flexible working hours and possibility for mobile work Safe workplace in an innovative scientific environment Extensive internal and external training opportunities Additional service Modern working conditions and collegial corporate culture Compatibility of family and occupation