Senior IAM Validation Lead – Remote (GxP)

Sii Poland; Poznań; Remote; PLN 120,000 - 180,000; Full time

Job summary

Sii Poland seeks a Senior Validator to lead lifecycle validation for a global IAM platform, ensuring GxP compliance and readiness for audits. Remote work is supported across Poland and Ukraine, with collaboration across Quality, IT, and Security to translate regulatory requirements into practical controls.

You will drive validation strategy, documentation, and testing, while managing changes and ensuring ongoing validated state. English proficiency is essential for cross-border collaboration.

Qualifications

• 5+ years of validation experience in regulated environments (GxP).
• Deep knowledge of GxP, GAMP 5, and EU GMP Annex 11 regulations.
• Strong understanding of FDA 21 CFR Part 11 implications for validation.
• Experience creating validation documentation: requirements, risk assessments, validation reports.
• Advanced level of English.

Responsibilities

• Define and maintain the validation strategy, scope, and lifecycle controls for the IAM platform.
• Prepare, review, and approve complete validation documentation with traceability.
• Define risk-based testing for IAM processes like identity, accounts, and access rights.
• Assess changes/releases for GxP impact and define validation and regression tests.
• Manage deviations and CAPAs per procedures and verify evidence before closure.
• Maintain validated state through change control, periodic reviews, and supplier oversight.
• Clarify responsibilities and data ownership across IAM and connected apps.
• Represent IAM validation in audits and inspections, explaining scope, controls, and risks.
• Identify compliance gaps and lead improvements to automate assurance activities.

Skills

GxP knowledge

Regulated validation

Cross-functional collaboration

Documentation skills

Advanced English

Job description

Sii Poland seeks a Senior Validator to lead lifecycle validation for a global IAM platform, ensuring GxP compliance and readiness for audits. Remote work is supported across Poland and Ukraine, with collaboration across Quality, IT, and Security to translate regulatory requirements into practical controls.

You will drive validation strategy, documentation, and testing, while managing changes and ensuring ongoing validated state. English proficiency is essential for cross-border collaboration.