Senior IAM Validation Lead - GxP, Remote

Sii Poland; Wrocław; Teletrabalho; PLN 180 000 - 260 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Great Place to Work

Profit sharing

Medical care

Internal trainings

Open management

Resumo da oferta

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform. You will ensure GxP processes stay compliant, controlled, and ready for audits as the platform evolves, collaborating with Quality, IT and Security.

This role offers remote work from anywhere in Poland or Ukraine, enabling cross-functional work and ongoing improvements to validation strategies and supplier oversight.

Qualificações

• 5+ years in validation within regulated environments (GxP).
• Expertise in GxP, GAMP 5 and EU GMP Annex 11.
• Strong understanding of FDA 21 CFR Part 11 implications.
• Experience creating validation docs: requirements, risk assessments, reports.
• Ability to collaborate with Quality, IT and Security.
• Advanced English proficiency.

Responsabilidades

• Define and maintain the IAM validation strategy, scope, and lifecycle controls.
• Prepare, review, and approve validation documentation with traceability.
• Define testing approach based on risk for IAM processes (identity, access, roles).
• Assess changes/releases for GxP impact and plan validation and regression testing.
• Manage deviations and CAPAs with investigations and evidence verification.
• Maintain validated state via change management and periodic reviews.
• Clarify data ownership across IAM and connected apps.
• Interact with Quality, System and Process Owners to deliver compliant solutions.
• Represent IAM validation in audits and inspections with clear evidence.

Conhecimentos

GxP validation

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Documentation & audits

Cross-functional collaboration

English proficiency

Descrição da oferta de emprego

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform. You will ensure GxP processes stay compliant, controlled, and ready for audits as the platform evolves, collaborating with Quality, IT and Security.

This role offers remote work from anywhere in Poland or Ukraine, enabling cross-functional work and ongoing improvements to validation strategies and supplier oversight.