Senior Digital Transformation & IT Compliance Consultant | Senior Digital Transformation & IT Compliance Consultant
KVALITO AG
Job Summary
This senior consulting role in Basel, Switzerland, focuses on leading complex digital transformation initiatives within regulated Life Sciences organizations (Medical Devices, Biopharma, Pharmaceuticals). The consultant will operate at the critical junction of Operational Technology (OT), Quality Management, Computerized System Validation (CSV), and Information Security. Key responsibilities include defining strategic roadmaps, guiding major ERP (SAP S/4HANA) and OT system implementations, and establishing robust validation frameworks compliant with global standards like 21 CFR Part 11 and EU Annex 11. This high-impact position requires a strategic thinker with at least 15 years of industry experience and exceptional leadership skills to act as a trusted advisor to senior stakeholders, ensuring secure, scalable, and compliant systems across manufacturing and enterprise environments. The role involves significant international travel (up to 50%).
Required Skills
Education
Bachelor’s or Master’s degree in Pharmaceutical Sciences, Engineering, or Information Technology
Experience
- At least 15 years of experience in the Life Sciences sector (Medical Devices, Biopharma, and Pharmaceuticals)
- Proven leadership in IT and OT Quality Management Systems, including system onboarding, validation, and compliance in regulated global environments
- Solid experience in managing cyber and Information security in OT landscapes, including network segmentation and incident response
- Extensive expertise with MES, LIMS, QMS, and ERP solutions, including SAP S/4HANA and complex data migrations
- Hands-on experience with digital validation tools (e.g., Kneat, X-Ray, ValGenesis)
Languages
Additional
- Regional and international travel up to 50%. Must possess strong project leadership and program management capabilities and act as a trusted advisor to senior stakeholders.