E-Compliance Team Lead | Biologist (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
As the Regional/Local E-Compliance Team Leader, you will spearhead IT and Data Governance for Global Quality Assurance systems at a leading global healthcare company. Reporting to the Head of IT Governance, you will lead a high-performing team responsible for managing the IT QA portfolio and overseeing GxP projects worldwide. Your primary focus will be driving Computerized Systems Validation (CSV) compliance, specifically for SAP S/4 HANA and other regulated platforms. You will define risk-based validation strategies, oversee global system deployments, and manage IT vendor relationships. This role is unique for its involvement in cutting-edge initiatives, including leading the global validation strategy for Generative AI deployment within GxP environments. You will act as a critical bridge between Quality Assurance and IT, ensuring that digital quality roadmaps and process automation initiatives align with the company's 2030 vision for sustainable healthcare innovation.
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 across GxP and SOX/JSOX modules
- Proven leadership experience in building and mentoring global high-performing teams
Languages
Additional
- Experience with GAMP 5 (1st edition required; 2nd edition preferred); expertise in global system deployments (DSI and DSJ regions); ability to lead validation strategies for Generative AI in regulated environments.
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