Global E‑Compliance & IT Quality Project Lead (m/f/d) Driving validation excellence and QA governance in a worldwide technology landscape Location: Global/Remote Options Function: IT Quality, Computerized Systems Validation (CSV), Global Project Leadership About the Role We are seeking an experienced Global E‑Compliance & IT Quality Project Lead to oversee strategic and operational IT Quality initiatives across a worldwide organization. In this role, you will guide the regional and local E‑Compliance teams while steering large‑scale, multinational GxP and IT Quality projects. Your primary focus will be the leadership of global CSV programs, development of risk‑based validation approaches, and ensuring compliance across critical GxP‑related IT systems. This includes major global platforms such as SAP S/4HANA and other regulated applications. You will be deeply involved in shaping global validation strategies, driving digital QA transformation, and ensuring operational excellence across a distributed system landscape. Key Responsibilities Strategy & Global Governance Lead global strategies for CSV, IT Governance, and Data Integrity. Develop and refine validation frameworks in collaboration with cross‑functional QA teams. Drive digital quality initiatives, automation programs, and continuous improvement efforts. Establish global validation strategies for emerging technologies, including Generative AI in GxP environments. Governance & Oversight Maintain quality governance for global IT Quality systems (e.g., QMS platforms, document systems, validation lifecycle tools) following SDLC principles. Ensure compliance with applicable international regulations and internal frameworks. Oversee vendor qualification, vendor management, and outsourced CSV activities. Implementation & Operational Support Lead execution of global IT Quality strategies aligned with business and QA objectives. Provide e‑Compliance leadership for system deployments, migrations, and ongoing operations. Support audit and inspection readiness in collaboration with IT and QA partners. Leadership & Team Development Build, mentor, and lead a high‑performing global E‑Compliance team. Advance cross‑functional collaboration with international IT, QA, and business stakeholders. ⚠️ Risk Management Oversee risk identification and mitigation across computerized systems. Act as the primary QA representative in global IT/CSV governance forums. Ensure quality oversight for third‑party vendors and global CSV activities. Continuous Improvement Drive innovation and enhance organizational maturity in technology and quality operations. Address and resolve gaps in e‑Compliance and IT Quality processes. Communicate IT‑related risks and improvement recommendations clearly to leadership. Qualifications & Experience 10 years in GxP environments, including 5 years in global QA, CSV, or IT Quality roles. Significant experience with global Computerized System Validation, especially SAP S/4HANA. Strong knowledge of ISPE GAMP 5 (1st edition required; 2nd edition beneficial). Proven record in leading global teams and projects in a complex, multinational environment. Degree in a scientific or technical field (Master's preferred). Excellent English communication skills, both written and verbal. Strong project management skills with a global, enterprise‑wide mindset. In‑depth understanding of QMS, GxP regulations, IT governance, data integrity, and regulatory expectations. Strong interpersonal capabilities, including collaboration, conflict resolution, and stakeholder management. Why This Role? This position is ideal for a senior professional who wants to influence global quality and compliance landscapes, lead high‑impact technology initiatives, and shape the future of IT Quality within a complex and international environment. SThree_Germany is acting as an Employment Agency in relation to this vacancy.