Senior IAM Validation Lead – Remote (GxP)

Sii Poland; Piła; Remote; PLN 180,000 - 240,000; 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

MySii app

Medical care

Job summary

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global Identity and Access Management platform. You will ensure GxP functions stay compliant, controlled, and audit-ready, collaborating with Quality, IT, and Security across Poland and Ukraine.

You will define strategy, prepare validation documents, and drive risk-based testing and change control to keep the platform validated as it evolves. Strong English is essential.

Qualifications

• Minimum 5 years of validation experience in regulated environments (GxP).
• In-depth knowledge of GxP, GAMP 5 and EU GMP Annex 11.
• 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 cross-functional teams (Quality, IT, Security).
• Advanced English language skills.

Responsibilities

• Define and maintain the validation strategy, scope, and lifecycle controls for the IAM platform supporting GxP processes.
• Prepare, review, and approve complete validation documentation with traceability.
• Define testing approaches based on risk for IAM processes like identity management and access controls.
• Assess changes and releases for GxP impact and define required validation and regression tests.
• Manage deviations and CAPAs in line with procedures and verify evidence before closure.
• Maintain validated state through change control, periodic reviews, and supplier oversight.
• Clarify responsibilities and data ownership across IAM and connected apps.
• Collaborate with Quality, System, and Process Owners to resolve risks and deliver compliant solutions.
• Represent IAM validation in audits and inspections, explaining scope, controls, and evidence.
• Identify compliance gaps and lead improvements to automate assurance activities.

Skills

GxP validation

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Cross-functional collaboration

Advanced English

Job description

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global Identity and Access Management platform. You will ensure GxP functions stay compliant, controlled, and audit-ready, collaborating with Quality, IT, and Security across Poland and Ukraine.

You will define strategy, prepare validation documents, and drive risk-based testing and change control to keep the platform validated as it evolves. Strong English is essential.