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

Key Responsibilities

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.

Profile

Education

• 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.

Experience

• 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)

We Offer

• Excellent Benefits
• Work-Life-Balance
• Growth and Development
• Health and Wellbeing Support

Further Informations

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

Apply now

For more information: www.daiichi-sankyo.eu

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Veröffentlicht am 01. Nov. 2026

Veröffentlicht am 01. Nov. 2026

Quelle: Statistisches Bundesamt (Destatis), Tabelle; dl-de/by-2-0; eigene Berechnung