EMEA Computerized Systems Quality Lead (SAP/eQMS)

Santen; Amsterdam; On-site; EUR 82,714,000 - 113,732,000; Full time

Benefits offered by this job

Competitive salary

Job summary

Santen is seeking an experienced Quality Cluster Lead, Computerized Systems to oversee CSQ activities across the EMEA region. You will ensure SAP S/4HANA, QMS platforms (Veeva, TrackWise, DocuSign), IT infrastructure and external providers operate in a compliant and inspection-ready state, partnering with DIT and global stakeholders.

The role drives governance, risk-based decisions, and continuous improvement of SAP QM, data governance and eQMS rollouts, while preparing for health authority

Qualifications

• 10+ years of industrial experience; at least 3 years in pharma/biotech/medical device.
• At least 5 years in Computerized System Quality Review and Validation, including SAP, Veeva and TrackWise.
• Experience with multinational companies and eQMS rollout projects in cross-functional environments.
• Fluent English and a relevant degree.

Responsibilities

• Lead the EMEA Computerized System Quality Team and set priorities.
• Define strategy for CSQ oversight across SAP S/4HANA, QMS platforms.
• Ensure governance, validation strategies, risk-based SAP changes.
• Ensure GxP compliance and regulatory readiness across EMEA.
• Drive SAP QM data quality and master data governance.
• Support eQMS rollouts and audits, health authority inspections.
• Represent EMEA Quality in global CSQ initiatives and governance.

Skills

Quality governance

Cross-functional leadership

Risk-based decision making

Data analysis

GxP compliance

Regulatory inspections experience

Intercultural awareness

Communication skills

Education

Bachelor's degree in Pharmacy, Science, Engineering, Data Science or related

Tools

SAP

Veeva

TrackWise

DocuSign

Salesforce

Job description

Santen is seeking an experienced Quality Cluster Lead, Computerized Systems to oversee CSQ activities across the EMEA region. You will ensure SAP S/4HANA, QMS platforms (Veeva, TrackWise, DocuSign), IT infrastructure and external providers operate in a compliant and inspection-ready state, partnering with DIT and global stakeholders.

The role drives governance, risk-based decisions, and continuous improvement of SAP QM, data governance and eQMS rollouts, while preparing for health authority