Director (m/w/d) E-Compliance/ IT Governance

As Regional/Local E-Compliance Team Leader, you will steer CSV, IT governance, and data integrity across Global QA systems. You will lead the regional/global E-Compliance team, guiding IT QA portfolios and GxP projects worldwide. You will define risk-based validation strategies for SAP S/4 HANA and other regulated systems, ensuring compliance and audit readiness. You will collaborate with DX-IT and cross-functional teams to advance the digital quality roadmap and support global deployments. This role offers a strategic chance to shape QA IT governance and drive compliant, scalable solutions in a global pharma setting.

• Lead global CSV, IT governance, and data integrity initiatives
• Collaborate with QA teams to develop validation and governance strategies
• Drive the digital quality roadmap and process automation aligned with QMS
• Lead global validation strategy for Generative AI in GxP environments
• Implement and maintain Global QA governance for ALTOS, eQMS, QualityDocs, VLM and related QA data systems
• Ensure compliance of global Quality IT systems with regulations
• Oversee IT vendor selection and management for CSV activities
• Provide e-Compliance support for global system deployments and regulatory readiness
• Lead execution of IT quality strategies aligned with business objectives
• Foster collaboration with DX-IT to meet IT and regulatory requirements
• Support QA audits and inspections with DX-IT and Functional QA teams
• Build and mentor a high-performing global E-Compliance team
• Manage third-party/vendor oversight for CSV activities
• Represent QA in IT/CSV governance forums and communicate risks to leadership
• Identify and mitigate computerized system risks through cross-functional collaboration
• Lead initiatives to advance organizational technology and quality
• Ensure timely closure of operational gaps in e-Compliance QA and IT activities
• Collaborate with QA audit teams to communicate IT-related observations and risks

• Minimum 10 years in GxP roles
• At least 5 years in Global GxP QA or equivalent
• At least 5 years managing CSV or quality IT systems globally
• Strong knowledge of ISPE GAMP 5 (1st edition required; 2nd edition knowledge preferred)
• Proven global project and people management experience
• Bachelor in a scientific or technical discipline; Master preferred
• Extensive experience in validation and qualification of SAP S/4 HANA
• Fluent in English with strong communication skills
• Enterprise-minded with strong PM and organizational skills
• Deep understanding of GxP, CSV, IT governance, data integrity, regulatory expectations
• Collaborative, conflict resolution, and shared accountability skills

• leadership
• collaboration
• communication
• Computerized Systems Validation (CSV)
• SAP S/4 HANA validation
• GxP regulations