Senior IAM Validation Lead - GxP & Audits (Remote)

Sii Poland; Województwo mazowieckie; À distance; PLN 160 000 - 260 000; Plein temps

Avantages offerts par ce poste

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

Résumé du poste

Sii Poland seeks a Senior Validator to lead lifecycle validation for a global Identity and Access Management platform. You will ensure regulated GxP processes stay compliant, controlled, and audit-ready, collaborating with Quality, IT, and Security to translate regulatory requirements into effective controls.

The role offers remote work from anywhere in Poland or Ukraine, with a focus on maintaining a validated IAM environment, handling deviations and CAPAs, and representing validation in audits

Qualifications

• Minimum 5 years of validation experience in regulated environments (GxP).
• Deep knowledge of GxP, GAMP 5, EU GMP Annex 11.
• Understanding FDA 21 CFR Part 11 and its implications for validation.
• Experience creating and maintaining validation documentation.

Responsabilités

• Defining and maintaining the validation strategy, scope, system boundaries, and lifecycle controls for the IAM platform supporting GxP processes.
• Planning, preparing, reviewing, and approving complete and traceable validation documentation.
• Defining a testing approach based on risk and reviewing evidence for IAM processes such as identity/account management, roles/access rights, and security controls.
• Assessing changes, software releases, and configuration changes for GxP impact and defining required validation/testing.
• Managing validation-related deviations and CAPAs with investigations and evidence verification.
• Keeping the platform validated through change management, reviews, and supplier oversight.
• Clarifying responsibilities and data ownership across IAM and connected apps.
• Working with Quality, System Owners, 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 simplify/automatize assurance activities.

Connaissances

GxP validation

Regulatory compliance

Cross-functional collaboration

Risk assessment

English proficiency

Outils

Automated validation tools

Cloud-based IAM

Description du poste

Sii Poland seeks a Senior Validator to lead lifecycle validation for a global Identity and Access Management platform. You will ensure regulated GxP processes stay compliant, controlled, and audit-ready, collaborating with Quality, IT, and Security to translate regulatory requirements into effective controls.

The role offers remote work from anywhere in Poland or Ukraine, with a focus on maintaining a validated IAM environment, handling deviations and CAPAs, and representing validation in audits