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We are currently looking on behalf of one of our important clients for an IT Quality Assurance & CSV Manager (German Speaking). The role is a permanent position based in Solothurn Canton & comes with some home office allowance. Your Role: Carry out personnel, technical & people life cycle management of a IT QA & CSV team. Act as a key contact person & all-rounder in the field of IT Quality Assurance & Computer Systems Validation. Advise & support system owners, project managers or suppliers in the validation of computer systems according to internal & external GxP/GAMP specifications (eg in the field of production systems SW, SW development, MES or database systems). Independently prepare the necessary documentation & execution of tests. Support the continuous development of IT processes (eg further development of internal CSV processes or certification of IT service areas according to ISO 27001: Information Security). Act as a key contact person as a CSV expert for customers & audits. Review & approval CSV & system documentation. Your Skills: At least 5 years of relevant professional experience including experience in IT Quality Assurance, Computer Systems Validation & Computer Software Assurance. A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure. Experienced with Q-Systems (eg EU: Annex 11/FDA: 21CFR Part 11). Ideally experienced in the Medical Technology Sector. A knowledge of important IT Standards & Methods (eg ISO27001, ISO 80002-2, ITIL) or ISO 13485:2016 QMS for Medical Devices. Your Profile: Completed relevant Scientific or Technical University Degree. Strong communication skills, assertive & highly quality-oriented. Fluent English & good German language skills (to at least B2 Level) are a mandatory requirement.