Senior IT Quality Consultant (IT) (m/f/d)

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Senior IT Quality Consultant (IT) (m/f/d) Our client, an international pharmaceuticals company offers an interesting and exciting opportunity. The perfect candidate is a senior profile with proven experience of quality assurance and compliance that can hit the ground running. We need someone with experience in regulatory compliance for Diagnostics and Medical Devices (please not experience in pharma will not match our need). This person should show experience as not only a validation lead (focusing on internal guidance) but also show knowledge of the regulatory background that led to the specific guidance. Your role as Senior IT Quality Consultant (IT) Provide compliance advice and support to ensure that activities are conducted in accordance to internal Roche procedures, international standards (GxP, ICFR, GAMP) and Health Authority regulations.Proactively reviews andanalyze working practices, as well as results of inspections, audits and metrics/key performance indicators and advises the management team of potential impact from a compliance / process perspective.Oversee quality and compliance related activities, such as validation, qualification, system risk assessments, etc., for the assigned DIA IT systems; Provide consultancy to stakeholders regarding IT compliance, processes and standards considering the fast pacing agile IT environmentOngoing support of ITSM processes, e.g. Change- and Configuration management; Consulting of system support & project teams concerning IT Quality Assurance and Compliance topics (such as CSV, GDPR, ICFR, etc.)Participation in execution, documentation and tracking of internal and external IT audits (Co-Auditor); Participation in the development of compliance specifications, based on guidelines, legal requirements and policies and their review; Oversight or execution of periodic reviews of DIA IT systems.Required skillsMin 5 years of experience in a similar role with understanding of regulatory background leading to internal guidance Proven experience in regulatory compliance (CSV, Data Integrity, ICFR, GDPR, etc) Experience in Diagnostics/Medical Devices Experience with Agile frameworks Bachelor or Master Degree in Business Informatics or EngineeringProven adaption of regulatory compliance rules to new technologies (e.g. Cloud computing, RPA, machine learning) in a leading positionProven working experience in IT Quality Assurance functions (Validation Lead, Quality management, Auditing) in the medical device or pharmaceutical industry.Passionate about supporting and consulting IT delivery teams to strive for compliance in a collaborative wayEager to manage, improve, monitor and automate IT quality processes as a basis for data driven decision making (ITIL, COBIT certification are welcome)Experience in outsourcing of IT services (Offshoring, Cloud-Migration, testcenter,etc.Proven working experience in CSV in agile frameworks (SCRUM, SAFe) Experience in SOC reporting ½CISA certificationLean Six Sigma certificationGerman speaking skillsFurther informationlocation: Basel, Switzerlandstart date: April 2021 duration: 3 months Interested? If you would like to apply for this pharmaceutical project as Senior IT Quality Consultant (IT) , please contact Hoa Ha more information. Or you can apply directly by clicking the Apply button.We are looking forward to your application.Sthree Switzerland is acting as an Employment Business in relation to this vacancy.