> Markdown version of [/jobs/ext/3721859-director-ecompliance-it-governance](https://www.wearedevelopers.com/jobs/ext/3721859-director-ecompliance-it-governance). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Director, eCompliance / IT Governance - **Company:** Daiichi Sankyo - **Location:** Munchen, Germany - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Artificial Intelligence, Data Integrity, IT Management, Microsoft Office, SAP (Applications), SAP Implementation, System Testing, Generative AI, Information Technology, SAP S/4HANA, GXP - **Published:** October 14, 2026 - **Apply:** https://careers.daiichisankyo.com/job/Director-(mwd)-E-Compliance-IT-Governance/916-en_US/ ## About the Role * Bachelor's degree in a scientific, engineering, information technology, computer science, pharmacy, or related discipline required. * Master's degree or higher (e.g., M.Sc., MBA, PharmD, Ph.D.) preferred., * Minimum 12 years of experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry. * Minimum 7 years of leadership experience managing regional and global teams and cross-functional organizations. * Significant experience supporting pharmaceutical manufacturing operations and associated with GxP quality systems. * Extensive experience leading Computerized System Validation (CSV) programs for regulated environments. * Demonstrated expertise with SAP S/4HANA validation, governance, implementation, or support. * Strong background in GMP Quality Assurance and Quality Systems oversight. * Experience establishing and operating IT Governance frameworks. * Experience supporting regulatory inspections and audits by FDA, EMA, PMDA, MHRA, NMPA, or other health authorities. * Fluent in English with excellent verbal and written communication skills. Technical Knowledge * GAMP 5 (2nd Edition preferred) * FDA 21 CFR Part 11 * EU GMP Annex 11 * Data Integrity and ALCOA+ principles * ICH Quality Guidelines * Risk-based Validation methodologies * Quality Management Systems (QMS) * SAP S/4HANA ERP platforms * IT Governance and Compliance frameworks * Microsoft Office 365 * Generative AI * SOX/JSOX Compliance Requirements (preferred) ## Description The Director, eCompliance / IT Governance is responsible for leading DSE eCompliance / IT Governance, and Computerized System Validation (CSV) programs across DSE and its affiliates in EU. This role provides strategic leadership for Quality and IT compliance, ensuring regional and global GxP systems, SAP S/4HANA platforms, and digital quality initiatives remain compliant with regulatory requirements and corporate governance standards. The position leads a DSE regional team and partners with Quality, Manufacturing, Supply Chain, IT, and business stakeholders to support digital transformation, inspection readiness, and operational excellence., * Develop and execute the DSE regional eCompliance and IT Governance strategy aligned with business objectives and Quality Management System (QMS) requirements. * Promote and maintain global standards, policies, and procedures for Computer System Validation (CSV), IT Governance, and Data Integrity. * Serve as a senior advisor to executive leadership on regulatory compliance, digital quality transformation, and governance of emerging technologies. * Drive continuous improvement initiatives that enhance compliance, operational efficiency, and digital capabilities across the organization. * Lead, develop, and mentor a high-performing DSE eCompliance and IT Governance organization. * Foster a culture of accountability, quality, compliance, innovation, and continuous learning. * Support succession planning, organizational capability development, and talent acquisition initiatives to ensure long-term organizational success., Computerized System Validation (CSV) & IT Compliance * Provide strategic oversight of regional and global CSV programs for GxP-regulated systems across manufacturing, quality, supply chain, and corporate functions. * Establish and maintain risk-based validation frameworks in accordance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, Data Integrity guidance, and company standards. * Ensure compliant validation and lifecycle management of SAP S/4HANA and other critical enterprise platforms. * Oversee qualification activities for infrastructure, cloud platforms, applications, automated equipment, interfaces, and supporting technologies. * Lead governance for emerging technologies, including AI-enabled and advanced digital solutions used in GxP environments. SAP S/4HANA Governance and Quality Oversight * Provide global Quality and Compliance leadership for SAP S/4HANA deployment, validation, change management, maintenance, and continuous improvement activities. * Partner with business process owners and DX/IT organizations to ensure compliant implementation of SAP modules supporting manufacturing, supply chain, quality, finance, and regulatory operations. * Develop appropriate validation, qualification, and compliance strategies for regulated and non-regulated SAP functions, including SOX/JSOX impacted processes. * Support global template governance and deployment activities across multiple regions. Further Key Responsibilities Quality Assurance & Manufacturing Compliance * Ensure Quality oversight of computerized systems supporting pharmaceutical manufacturing, laboratories, supply chain operations, and quality processes. * Partner closely with Manufacturing QA, Quality Systems, Regulatory Affairs, and other quality functions to ensure inspection readiness and regulatory compliance. * Support health authority inspections, internal audits, supplier audits, and regulatory inquiries involving computerized systems and data integrity. * Provide expert guidance regarding GxP regulations, Data Integrity expectations, and quality risk management. IT Governance, Risk Management & Internal Controls * Establish governance frameworks to ensure effective management of IT-related risks and compliance obligations. * Provide oversight of IT infrastructure and platforms that host or support GxP applications and systems. * Represent Quality Assurance (QA) on the Change Advisory Board (CAB), reviewing and approving change management activities. * Monitor regulatory trends and assess their impact on Quality and IT compliance programs. * Escalate significant compliance risks and recommend mitigation strategies to senior management.