Senior IAM Validation Lead - GxP Compliance (Remote)

Sii Poland; Rzeszów; Teletrabalho; PLN 180 000 - 240 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Great Place to Work

Profit sharing

Medical care

Centre of internal trainings

Regular integration events and trips

Resumo da oferta

Sii Poland seeks a Senior Validator to lead lifecycle validation for a global IAM platform. You will ensure GxP compliance, maintain validated state, and coordinate with Quality, IT, and Security to translate regulatory requirements into effective controls.

The role supports remote work from Poland or Ukraine and involves defining validation strategy, assessing changes, and managing deviations to ensure audit-ready documentation and ongoing compliance.

Qualificações

• 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.

Responsabilidades

• Define and maintain the validation strategy, scope, and lifecycle controls for the IAM platform.
• Prepare, review and approve complete validation documentation with traceable evidence.
• Define testing approach based on risk for IAM processes such as identity and access management.

Conhecimentos

GxP regulatory knowledge

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Validation documentation

Cross-functional collaboration

English (Advanced)

Validation tools

Ferramentas

Validation tools

Descrição da oferta de emprego

Sii Poland seeks a Senior Validator to lead lifecycle validation for a global IAM platform. You will ensure GxP compliance, maintain validated state, and coordinate with Quality, IT, and Security to translate regulatory requirements into effective controls.

The role supports remote work from Poland or Ukraine and involves defining validation strategy, assessing changes, and managing deviations to ensure audit-ready documentation and ongoing compliance.