Senior CSV & IAM Validation Lead (Remote)

Remote Auto; Polska; Hybrid; PLN 180,000 - 280,000; Full time

Benefits offered by this job

Fully remote

Job summary

Remote Auto is seeking a Senior CSV Expert to lead lifecycle validation for a global IAM platform. You will ensure GxP compliance, maintain the validation strategy, and collaborate across Quality, IT, Security, and business teams to meet regulatory requirements and audit readiness.

The role is fully remote, with work possible from Poland or Ukraine, and focuses on risk-based testing and change control to keep the system validated and compliant.

Qualifications

• Minimum 5 years of experience in system validation within regulated environments.
• Deep expertise in GxP, GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11.
• Strong command of validation documentation practices and lifecycle controls.
• Experience in assessing GxP impact of changes and managing deviations.

Responsibilities

• Define and maintain the validation strategy, scope, and lifecycle controls for the IAM platform.
• Plan, review, and approve complete validation documentation with traceability and risk assessments.
• Lead testing approaches for identity and access management processes and security controls.
• Represent validation in audits and regulatory inspections; explain scope and controls.

Skills

GxP compliance

Validation leadership

Documentation

English proficiency

Tools

GAMP 5

Job description

Remote Auto is seeking a Senior CSV Expert to lead lifecycle validation for a global IAM platform. You will ensure GxP compliance, maintain the validation strategy, and collaborate across Quality, IT, Security, and business teams to meet regulatory requirements and audit readiness.

The role is fully remote, with work possible from Poland or Ukraine, and focuses on risk-based testing and change control to keep the system validated and compliant.