IT Compliance and Validation Expert, GxP, CSV

Responsibilities

• Strategic planning and independent management of IT compliance and CSV projects in regulated industries.
• Development, implementation, and optimization of tool-supported validation processes.
• Conducting gap and risk analyses and ensuring compliance with GxP regulations (FDA, EU-GMP, GAMP5).
• Validation of cloud or on-premise IT systems in agile or traditional projects.
• Advising clients on regulatory requirements and continuous improvement of validation processes.
• Using and contributing to the introduction of innovative technologies, e.g., AI‑assisted validation or modern ALM tools.

Requirements

• At least 3–5 years of professional experience in a GxP environment and knowledge of regulatory requirements (EU/US, FDA CFR Title 21 Part 11, EU GMP Annexes 11/15, GAMP5).
• Experience in independently managing projects as well as coordinating and setting the strategic direction of validation projects.
• Familiarity with agile methods (SCRUM) and experience with tools such as JIRA and Confluence.
• Structured, analytical working style and strong quality awareness.
• Excellent communication skills in German (C1 level) and English.
• Experience with ALM tools or AI‑assisted validations is a plus.