Quality Cluster Lead Computerized Systems

Santen·Amsterdam, NH, Netherlands

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About the role

Leads EMEA Computerized System Quality activities for SAP, eQMS platforms, IT infrastructure and external providers. The role manages the regional team, quality governance, validation, risk assessments, periodic reviews, audits and inspection readiness, and represents EMEA Quality in global initiatives. Requires 10+ years of industrial experience, including 3+ years in pharmaceutical, biotech or medical device environments, and at least 5 years in computerized system quality review and validation.

Key requirements

• B.A./B.Sc. or equivalent university degree in Pharmacy, Science, Engineering, Data Science or a related discipline, with fluent English.
• At least 10 years of relevant experience
• Required skills: Computerized System Quality Review and Validation, SAP quality governance, SAP S/4HANA, eQMS oversight, Risk assessment, Quality governance, GxP compliance, Regulatory inspection readiness, Cross-functional team leadership, Data governance, Advanced data analysis, Risk-based quality and compliance decision-making, Quality requirements translation, Audit and inspection support
• Required language: English

Opportunity details

• Workplace: Hybrid
• Posted: Oct 12, 2026
• Original advert language: English

Full vacancy

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Employer’s role description

Manage the Santen EMEA Computerized System Quality Team, leading, coaching and developing team members, ensuring appropriate competency and GxP training, and managing budget, resources and priorities. Act as the first point of contact for Information System and Computerized System Quality compliance matters within EMEA.
Define and lead the strategy for Computerized System Quality oversight across SAP systems, including SAP S/4HANA, MMDM and the SAP EMEA landscape, electronic QMS platforms such as Veeva, TrackWise and DocuSign, IT infrastructure, cybersecurity and external service providers.
Ensure effective Quality Governance for the Santen EMEA SAP S/4HANA solution, including compliant governance, validation approaches and lifecycle controls. Translate Quality requirements into system/application requirements and ensure risk-based decisions are applied to SAP changes and releases, while representing EMEA Quality in cross-functional and global SAP governance forums.
Hold overall responsibility for the effective and efficient application of Santen's GxP governance framework to computerized systems and supporting infrastructure across the EMEA region, ensuring compliance with applicable regulatory requirements and company standards.
Set direction and monitor the performance of SAP QM and Master Data quality activities, ensuring robust controls, data governance and sustainable compliance of quality-critical master data. Work closely with Master Data Management, IT/Digital and business stakeholders to drive harmonised data standards and consistent implementation across systems and service providers.
Drive continuous improvement in SAP QM processes, MDM data governance, Computerized System Quality Review and Validation processes. Ensure QA KPIs are retrieved from systems in a timely manner, SAP EMEA Quality and validation activities are completed on time, and SAP QM users are appropriately supported, coached and trained.
Lead or participate in EMEA Quality projects related to Computerized Systems and digital Quality, representing EMEA Quality in global Computerized System projects and ensuring regional requirements are addressed. Lead and support successful eQMS rollouts across EMEA in alignment with global strategies and regulatory expectations.
Provide Quality oversight for eQMS platforms and computerized systems across EMEA, including acting as a DocuSign Key User and eQMS process owner for platforms such as TrackWise and Veeva. Support quality integration activities and ensure eQMS tools remain compliant with applicable regulations.
Ensure timely execution of Periodic Reviews for Computerized Systems, IT infrastructure and external service providers across EMEA. Lead or coordinate Computerized System risk assessments and participate in or lead audits of computerized systems, suppliers and service providers.
Ensure EMEA Computerized System audit and inspection readiness, including representing EMEA Quality during Health Authority inspections and audits, providing required documentation and SME support, and fostering a strong Quality mindset within and beyond the EMEA Quality organisation.
Act as the EMEA representative within global computerized system and digital quality initiatives, ensuring EU regulatory requirements are appropriately reflected in global processes, standards, and implementations. Provide quality oversight and support to other regions, as applicable within the defined scope of responsibility.
Act as the primary EMEA Quality interface with DIT, SAP and global stakeholders, and lead the integration of cybersecurity and IT governance requirements into the Quality Management System for computerized systems.

Quality Cluster Lead Computerized Systems

About the role

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Full vacancy

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