Senior IAM Validation Lead - Remote (GxP & Audits)

Sii Poland; Toruń; Remote; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Great Place to Work

Solid financial situation

Contracts with the biggest brands

Centre of internal trainings

Many experts you can learn from

Open and accessible management team

Profit sharing

Passion Sponsorship program

Regular integration events and trips

Comfortable and well-equipped offices

MySii app

Medical care

Job summary

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform, ensuring compliance for GxP processes and readiness for audits. The role collaborates with Quality, IT and Security to translate regulatory requirements into controls and maintain a consistent validation approach across platform evolution.

The position offers flexible remote work from anywhere in Poland or Ukraine, with a focus on robust validation, traceability, and continuous improvement in a

Qualifications

• 5+ years in validation within regulated environments (GxP).
• Deep expertise in GxP, GAMP 5, EU GMP Annex 11.
• Strong understanding of FDA 21 CFR Part 11 implications for validation.
• Experience creating and maintaining validation docs (requirements, risk assessments, validation reports).
• Collaborate effectively with Quality, IT and Security teams.
• Advanced level of English.

Responsibilities

• Define and maintain validation strategy, scope, system boundaries, and lifecycle controls for the IAM platform.
• Plan, prepare, review, and approve traceable validation documentation with evidence.
• Define risk-based testing for IAM processes like identity management and access controls.
• Assess changes for GxP impact and plan validation and regression testing.
• Manage validation deviations and CAPAs per procedures, including evidence verification.
• Maintain validated state through change management and periodic reviews.
• Clarify data ownership across IAM and connected apps.
• Work with Quality, IT and Process Owners to resolve risks and deliver compliant solutions.
• Represent IAM validation in audits and inspections with clear scope and evidence.
• Identify compliance gaps and lead improvements to simplify assurance activities.

Skills

GxP validation

Regulatory compliance

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Validation documentation

Cross-functional collaboration

English proficiency

Tools

Cloud IAM solutions

Automated validation tools

Job description

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform, ensuring compliance for GxP processes and readiness for audits. The role collaborates with Quality, IT and Security to translate regulatory requirements into controls and maintain a consistent validation approach across platform evolution.

The position offers flexible remote work from anywhere in Poland or Ukraine, with a focus on robust validation, traceability, and continuous improvement in a