Head of Quality Assurance Unit of the Sponsor of the Faculty of Medicine OWL (m/f/d)

At the University of Bielefeld you have the chance to help shape the construction of a modern human medicine faculty. The Medical Faculty OWL pursues an innovative translation concept. The central element is the establishment of a center for translational medicine. In this structure, existing units – such as the Research Biobank, the Data Integration Centre for Medical Research and Biostatistics – are already networked closely with the Coordination Centre for Clinical Research Support Unit (CRSU) to be set up. The establishment of a sponsorship process for clinical studies also creates a quality assurance unit of the sponsor at the OWL Medical Faculty. In close coordination with the Dean's Office, you are responsible for the further design and construction of the essential organizational structures and process instructions for the quality management of the sponsor and the process for the introduction and maintenance of suitable quality assurance and development measures at the site. As head of the Quality Assurance Unit (QSE) of the Medical Faculty OWL, You monitor the operational implementation of clinical trials as part of the sponsor quality management and the acquisition of the sponsorship. QSE runs the takeover process and supports the applicants in questions. You work with the areas of the Centre for Translational Medicine, the Unit for Research and Career Development and the Hospital Carriers of the UK OWL (link: website of the University Hospital OWL) and the Heart and Diabetes Center NRW (HDZ). As part of the development of university medicine in the OWL region, the place to be occupied offers a supportive and faculty-like activity. The young faculty is characterized by short voting paths and an open and value-adding discussion culture. The framework conditions of the TV-L apply. The following position is to be placed in the OWL Faculty of Medicine: Senior Consultant (m/w/d) Reference number: Tech26059 Start: next possible Full time attractive remuneration (to be agreed depending on personal qualifications and task transfer) indefinite

technical and organizational management of the QSE unit of the university sponsor for clinical trials Expansion and maintenance of the sponsor quality management and sponsor SOP management in cooperation with the university clinics OWL Coordination of the application procedure and the evaluation of the acquisition of the university sponsor role for investigator-initiated clinical studies (IITs) Further development of the standardised risk assessment, the Vendorenqualification and the Sponsor Overights as part of the takeover of the sponsor role Consultation and support of examiners and study centres in quality and GxP questions Examination of sponsor-relevant documents (e.g. test plans, SOPs, monitoring concepts, risk assessments) Planning, implementation and follow-up of internal and external audits (e.g. system, study and service provider audits) Preparation, monitoring and follow-up of administrative inspections Compilation of regular sponsor quality reports and annual audit plans to ensure a high level of quality coordination of corrective and preventive measures (Corrective and Preventive Actions) and Serious Breaches in case of deviations and violations; Collection and implementation of audit and inspection measures Conception and implementation of training and training in the context of quality assurance in clinical research Exchange and cooperation with all participating institutions / areas in support of clinical trials Support in the planning and implementation of computer system validations (GAMP5)

We expect completed university studies (State exams, Diploma, (Uni)/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 extensive experience in the planning, organisation, financing and project management of IITs well-founded knowledge of relevant regulations (including ICH-GCP, EU-CTR, AMG and MDR/MPDG) Experience in regulatory advice on study-specific enquiries Experience in the planning and implementation of audits and/or inspection management very good analytical skills Creativity and independent, independent working Team and communication skills and ability to work independently high organisational competence, commitment, care and reliability Gender and diversity competence safe handling of common MS–Office products (including Word, Excel, PowerPoint) very good knowledge of German and English (in word and writing) We wish completed doctorate Training certificate in quality management in clinical research Practical experience in dealing with a common quality management and document steering system

attractive remuneration (to be agreed depending on personal qualifications and task transfer) indefinite Full time internal and external training opportunities Variety of health, consulting and prevention offers Compatibility of family and occupation safe workplace fixed place of service (Bielefeld) without travel flexible working hours FlexWork: basic possibility for mobile work (catch depending on the specific task field) good transport connection Additional operational care (VBL) collegial cooperation open and pleasant working atmosphere exciting and varied activities modern working environment with digital processes diverse offers (Mensa, Cafeteria, Restaurants, Uni-Shop, ATMs etc.)