Senior IAM Validation Lead - GxP Compliance (Remote)

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

Benefits offered by this job

Great Place to Work

Profit sharing

Medical care

Centre of internal trainings

Many experts you can learn from

Open and accessible management team

Job summary

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform. You will ensure GxP-compliant controls and readiness for audits, collaborating with Quality, IT, and Security teams.

You will translate regulatory requirements into practical validation approaches, define strategy, risk-based testing, and manage deviations, changes, and supplier oversight to keep the system in a validated state.

Qualifications

• Minimum 5 years of validation in regulated environments (GxP).
• Deep knowledge of GxP, GAMP 5, and EU GMP Annex 11.
• Understanding FDA 21 CFR Part 11 implications for system validation.
• Experience creating validation documents: requirements, risk assessments, validation reports.
• Ability to collaborate with Quality, IT, and Security teams.
• Advanced English.

Responsibilities

• Define and maintain the validation strategy, scope, and lifecycle controls for IAM platform.
• Plan, prepare, review, and approve traceable validation docs with evidence.
• Define testing approach based on risk for IAM processes: identity, access, roles, security controls.
• Assess changes/releases for GxP impact and define validation and regression tests.
• Manage deviations and CAPAs per procedures; verify evidence before closure.
• Maintain validated state via change management and periodic reviews.
• Clarify data ownership across IAM and connected apps.
• Collaborate with Quality, System, and Process Owners and service providers.
• 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

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Docs & reports

Cross-functional

English

Tools

Validation tools

Job description

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform. You will ensure GxP-compliant controls and readiness for audits, collaborating with Quality, IT, and Security teams.

You will translate regulatory requirements into practical validation approaches, define strategy, risk-based testing, and manage deviations, changes, and supplier oversight to keep the system in a validated state.