EU GxP Validation Lead – CSV & Data Platform Expert

Poland and Central-Eastern Europe; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Xebia seeks a validation-focused professional to lead GxP validation activities for our data platform. You will co-author validation documentation, prepare qualification records, and contribute to risk assessments and validation planning.

You will support IQ/OQ protocols, manage change-control processes, and assist with inspections, audits, and compliance readiness while collaborating with platform engineers, data teams, and stakeholders across the business.

Qualifications

• Experience in GxP-regulated environments.
• Hands-on with computer system validation (CSV) or equivalent frameworks.
• Experience creating and maintaining validation documentation.
• Knowledge of IQ/OQ execution and qualification reporting.
• Understanding of change control and validation lifecycle management.
• Familiarity with SOP creation and maintenance.
• Experience collaborating with quality/compliance stakeholders.

Responsibilities

• Lead and support GxP validation activities for the data platform.
• Co-author validation and qualification documentation (SOPs, reports).
• Prepare qualification records and traceability evidence.
• Contribute to risk assessments and validation planning.
• Support IQ/OQ protocols and validation execution.
• Ensure changes are managed through change-control processes.
• Assist inspections, audits, and compliance readiness.
• Collaborate with platform engineers, data teams, and business stakeholders.

Skills

GxP validation

CSV/validation

IQ/OQ execution

documentation

change control

regulatory compliance

cross-functional teamwork

Tools

Kneat

Databricks

Job description

Xebia seeks a validation-focused professional to lead GxP validation activities for our data platform. You will co-author validation documentation, prepare qualification records, and contribute to risk assessments and validation planning.

You will support IQ/OQ protocols, manage change-control processes, and assist with inspections, audits, and compliance readiness while collaborating with platform engineers, data teams, and stakeholders across the business.