IT Quality Assurance & CSV Manager (German Speaking)

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.