Senior Validation Lead for GxP IAM, Remote

Sii Poland; Lublin; Remote; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Great Place to Work

Internal trainings

Profit sharing

Medical care

Remote-friendly

Diverse team

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-compliant validation, translate regulatory requirements into controls, and maintain a validated state as the platform evolves.

You will collaborate with Quality, IT, and Security, define testing approaches based on risk, review validation docs, support audits, and drive improvements including automation and data ownership clarity.

Qualifications

• 5+ years of validation experience in regulated environments (GxP).
• Deep knowledge of GxP, GAMP 5, EU GMP Annex 11 regulations.
• Strong understanding of FDA 21 CFR Part 11 and its validation implications.
• Experience creating and maintaining validation documentation (requirements, risk assessments, validation reports).
• Ability to collaborate with Quality, IT, and Security teams.
• Advanced level of English.

Responsibilities

• Defining and maintaining the validation strategy, scope, system boundaries, and lifecycle controls for the IAM platform.
• Planning, preparing, reviewing, and approving complete validation documentation with traceability.
• Defining a testing approach based on risk for IAM processes and reviewing evidence.
• Assessing changes for GxP impact and defining required validation and regression testing.
• Managing deviations and CAPAs with investigation support and evidence verification.
• Keeping the platform validated via change management, reviews, and supplier oversight.
• Clarifying responsibilities and data ownership across IAM and connected apps.
• Collaborating with Quality, System, and Process Owners and service providers to resolve risks.
• Representing IAM validation in audits and inspections with clear scope, controls, risks, and evidence.
• Identifying compliance gaps and leading improvements to automate assurance activities.

Skills

GxP validation

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Cross-functional collaboration

English proficiency

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-compliant validation, translate regulatory requirements into controls, and maintain a validated state as the platform evolves.

You will collaborate with Quality, IT, and Security, define testing approaches based on risk, review validation docs, support audits, and drive improvements including automation and data ownership clarity.