CSV & Data Integrity Lead - Regulatory Compliance Expert

Servier; Ireland; Remote; EUR 90,000 - 130,000; Full time

Job summary

Servier is seeking a CSV Specialist & Site Data Integrity Lead to assure GxP-compliant computerised systems across the site. You will balance regulatory leadership with project-based validation support to embed validation throughout the lifecycle.

Responsibilities include overseeing data integrity, change controls, and audit readiness, while coordinating with IT, Quality and business teams to deliver compliant system qualifications.

Qualifications

• Third-level qualification in IT, Engineering or Quality.
• Demonstrated experience in Computer System Validation in regulated environments.
• Strong knowledge of data integrity and GxP principles.

Responsibilities

• Lead regulatory compliance and CSV governance across site.
• Coordinate change controls, periodic reviews and lifecycle management.
• Develop validation documentation (VMPs, protocols, reports, SOPs).
• Support audits, inspections and readiness activities.
• Collaborate with IT, Quality and business teams on validation deliverables.
• Ensure data integrity controls and training across groups.

Skills

CSV governance

Regulatory compliance

Data integrity

Risk assessment

Stakeholder engagement

Documentation

Education

Bachelor's degree IT/Engineering/Quality

Tools

ERP

MES

LIMS

Job description

Servier is seeking a CSV Specialist & Site Data Integrity Lead to assure GxP-compliant computerised systems across the site. You will balance regulatory leadership with project-based validation support to embed validation throughout the lifecycle.

Responsibilities include overseeing data integrity, change controls, and audit readiness, while coordinating with IT, Quality and business teams to deliver compliant system qualifications.