Introduction
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Director (m/w/d) E-Compliance/ IT Governance
About the Role
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.
Tasks
Strategic and People Leadership Responsibilities
- 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.
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
Mostramos trecho e link por vaga, e o texto integral quando a fonte permite. Marcas e logotipos citados pertencem aos seus titulares.
