E-Compliance Team Lead | Software Engineer (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
As the Regional/Local E-Compliance Team Leader, you will play a pivotal role in IT and Data Governance for Global Quality Assurance (QA) systems at a leading global healthcare company. Reporting to the Head of E-Compliance / IT Governance, you will manage a global team overseeing GxP projects and driving Computerized Systems Validation (CSV) compliance. Your daily responsibilities include defining risk-based validation strategies, providing operational oversight for GxP-related IT systems, and managing the CSV of complex platforms like SAP S/4 HANA. You will be at the forefront of digital transformation, leading global validation strategies for Generative AI deployment in GxP environments and driving process automation. This role is unique for its global scope, offering the opportunity to shape the digital quality roadmap and ensure regulatory compliance across more than 30 countries. It is an ideal position for a leader who excels at bridging the gap between IT governance, quality assurance, and innovative healthcare technology.
Required Skills
Education
Not specified
Experience
- Minimum 10 years of experience in GxP roles
- At least 5 years of experience in Global GxP Quality Assurance or equivalent
- At least 5 years of experience managing Computerized Systems Validation or quality IT systems on a global scale
- Extensive experience in SAP S/4 HANA validation and module functions (GxP, SOX/JSOX)
- Proven leadership experience in building and mentoring global teams
Languages
Additional
- Experience with SAP S/4 HANA deployment across DSI and DSJ regions; expertise in ISPE GAMP 5 (1st edition required, 2nd edition preferred); ability to support global inspections and audit readiness.
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