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

Job Title

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

About the Role

As the Regional/Local E-Compliance Team Leader reporting to the Head of E-Compliance / IT Governance, you will play a pivotal role in IT and Data Governance for Global Quality Assurance (QA) systems. You will lead the Regional/Local E-Compliance team, managing the IT QA portfolio and overseeing GxP projects globally. Your key focus will be driving Computerized Systems Validation (CSV) compliance by defining risk-based validation strategies and providing operational oversight of GxP-related IT systems worldwide.

You will be responsible for the CSV of SAP S/4 HANA and other regulated systems, including platform/infrastructure and tool qualification, as well as change management. Extensive experience in SAP S/4 HANA validation and a comprehensive understanding of various system functions and modules—including GxP, SOX/JSOX, and non-regulated areas—are essential. You will support SAP S/4 HANA deployment across the DSI and DSJ regions and maintain global deployments.

Key Responsibilities

• Strategy Deployment
• Lead global principles and strategies for CSV, IT governance, and data integrity.
• Collaborate with functional QA teams to develop tailored validation and governance strategies.
• Drive the digital quality roadmap and process automation initiatives aligned with the Quality Management System (QMS) strategy.
• Lead the global validation strategy for Generative AI deployment in GxP environments, working closely with DX-IT and cross-functional teams.
• Governance and Oversight
• Implement and maintain Global QA governance for systems such as ALTOS, eQMS, QualityDocs, VLM, and related QA data systems in accordance with Global Software Development Life Cycle (SDLC).
• Ensure compliance of global Quality IT systems with relevant regulations.
• Oversee IT vendor selection and management, including outsourced and insourced CSV activities.
• Implementation and Support
• Lead the execution of IT quality strategies aligned with business objectives.
• Provide e-Compliance support for global system deployments, ensuring regulatory compliance.
• Support inspections and audit readiness in collaboration with DX-IT and Functional QA teams.
• Team and Talent Development
• Build, lead, and mentor a high-performing global E-Compliance team.
• Foster effective collaboration with DX-IT to meet IT and regulatory requirements.
• Foster effective collaboration with DX-IT to meet IT and regulatory requirements.
• Further Key Responsibilities
• Risk Management
• Ensure quality oversight for third-party vendors and CSV activities in partnership with Functional QA.
• Serve as the primary contact for global RDPV QA CSV activities.
• Identify and mitigate computerized system risks through cross-functional collaboration.
• Represent QA in IT/CSV governance forums and communicate risks to leadership.
• Continuous Improvement
• 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 potential risks.

Qualifications and Experience

• Minimum 10 years of experience in GxP roles, including at least 5 years in Global GxP QA or equivalent.
• At least 5 years of experience managing Computerized Systems Validation or quality IT systems on a global scale.
• Strong knowledge of ISPE GAMP 5 (1st edition required; familiarity with 2nd edition preferred).
• Proven leadership capabilities with global project and people management experience.
• Bachelor’s degree in a scientific or technical discipline is required; Master’s degree preferred.
• Extensive experience in validation and qualification of SAP S/4 HANA.
• Fluent in English with excellent verbal and written communication skills.
• Enterprise mindset with strong project management and organizational skills.
• Deep understanding of quality management systems, GxP regulations, computerized system validation, IT governance, data integrity, and regulatory expectations.
• Exceptional collaboration, conflict resolution, and shared accountability skills.