Remote Senior IAM Validation Lead – GxP Compliance

Sii Poland; Szczecin; Remote; PLN 180,000 - 280,000; 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 supporting GxP processes. You will translate regulatory requirements into effective controls, collaborate with Quality, IT, and Security, and ensure ongoing compliance as the platform evolves.

Remote work from Poland or Ukraine is supported. You will drive validation strategies, documentation, and testing approaches, ensuring traceability and evidence before release.

Qualifications

• Minimum 5 years of validation experience in regulated environments (GxP).
• Deep expertise in GxP, GAMP 5 and EU GMP Annex 11 regulations.
• Strong understanding of FDA 21 CFR Part 11 and its implications for system validation.
• Experience creating and maintaining validation documentation (requirements, risk assessments, validation reports).
• Proven ability to collaborate with Quality, IT, and Security teams.

Responsibilities

• Define and maintain the validation strategy, scope, boundaries and lifecycle controls for the IAM platform.
• Prepare, review and approve complete, traceable validation documentation before release and during operation.
• Define testing approach based on risk; review evidence for key IAM processes.
• Assess changes for GMP impact and define required validation/regression testing.
• Manage validation deviations and CAPAs; support investigations and closure.
• Keep platform in a validated state via change management and periodic reviews.
• Clarify responsibilities and data ownership across IAM and connected apps.
• Collaborate with Quality, System and Process Owners and service providers to mitigate risks.
• Represent IAM validation in audits and inspections; explain scope, controls and evidence.
• Identify compliance gaps and lead improvements to simplify assurance activities.

Skills

GxP expertise

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Validation documentation

Cross-functional collaboration

Advanced English

Cloud IAM platforms

Automated validation tools

Spanish (intermediate)

Tools

Cloud IAM platforms

Automated validation tools

Job description

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform supporting GxP processes. You will translate regulatory requirements into effective controls, collaborate with Quality, IT, and Security, and ensure ongoing compliance as the platform evolves.

Remote work from Poland or Ukraine is supported. You will drive validation strategies, documentation, and testing approaches, ensuring traceability and evidence before release.