EMEA Computerized Systems Quality Lead | SAP & eQMS

Santen; Amsterdam; Hybrid; EUR 83,000 - 114,000; Full time

Benefits offered by this job

Competitive salary

Job summary

Santen seeks a Quality Cluster Lead, Computerized Systems to steward CSQ activities across the EMEA region. You will head the CSQ team, ensure SAP S/4HANA and electronic QMS platforms like TrackWise and Veeva stay compliant, and drive governance, validation, and data quality across systems and suppliers.

You will collaborate with DIT, SAP and global stakeholders to align regulatory expectations, deliver audits, and support eQMS rollouts across EMEA with a strong focus on risk-based decision

Qualifications

• 10+ years of industrial experience, including 3+ years in pharma/biotech/medical devices.
• Experience in Computerized System Quality Review and Validation, including SAP, Veeva and TrackWise.
• Multinational experience and eQMS rollout projects across cross-functional teams.

Responsibilities

• Lead the EMEA Computerized System Quality Team, coaching and prioritising with budget and resources.
• Define strategy for CSQ oversight across SAP, electronic QMS platforms, IT infra, and external providers.
• Ensure GxP governance, validation approaches, and lifecycle controls for SAP and QM systems.
• Drive continuous improvement of SAP QM processes, MDM data governance, and QA KPIs.
• Represent EMEA in global CSQ projects and ensure regional requirements are addressed.
• Oversee eQMS platforms (TrackWise, Veeva, DocuSign) in EMEA and ensure regulatory compliance.

Skills

Cross-functional leadership

Data analysis

GxP knowledge

English fluency

Problem solving

Intercultural awareness

Education

B.A./B.Sc. or equivalent in Pharmacy/Science/Engineering/Data Science

Tools

SAP

TrackWise

Veeva

DocuSign

Job description

Santen seeks a Quality Cluster Lead, Computerized Systems to steward CSQ activities across the EMEA region. You will head the CSQ team, ensure SAP S/4HANA and electronic QMS platforms like TrackWise and Veeva stay compliant, and drive governance, validation, and data quality across systems and suppliers.

You will collaborate with DIT, SAP and global stakeholders to align regulatory expectations, deliver audits, and support eQMS rollouts across EMEA with a strong focus on risk-based decision