CSV & Data Integrity Lead: Regulatory Compliance Expert

Servier (Ireland) Industries Ltd.

Bray (OK)

Hybrid

USD 87,000 - 127,000

Full time

9 days ago

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Benefits offered by this job

Health insurance

Flexitime

Hybrid pension

Job summary

Servier (Ireland) Industries Ltd. seeks a Computer System Validation (CSV) Specialist & Site Data Integrity Lead to ensure GxP systems are validated and maintained in a compliant state across the site.

This role blends regulatory compliance leadership (roughly 70%) with project-based validation support (about 30%), embedding validation principles through the lifecycle and maintaining continuous data integrity.

Qualifications

Essential: Third-level qualification in Information Technology, Engineering, or a Scientific/Quality discipline.
Demonstrated experience in Computer System Validation in a regulated environment.
Strong knowledge of regulatory compliance requirements (including US FDA expectations).
GxP systems and validation lifecycle; Risk-based validation principles.

Responsibilities

Regulatory compliance & CSV governance across the site; act as SME for data integrity.
Lead risk assessments and maintain data integrity risk management KPIs.
Coordinate change controls and ensure validation documentation (VMPs, protocols, reports).
Prepare for regulatory inspections and support audit readiness.
Collaborate with IT, Quality and Business teams on validation plans and traceability (IQ/OQ/PQ).