IAM Validation Specialist | Pharma (Hybrid)

We are looking for an IAM Validation Manager to ensure the validated state, compliance, and quality of an Identity & Access Management platform supporting GxP processes within a regulated pharmaceutical environment. In this role, you will combine Computerized System Validation expertise with a strong understanding of IAM processes, working across the full system lifecycle. You will define validation strategies, assess risks and changes, review testing evidence, manage deviations and CAPAs, and collaborate closely with Quality, IT, Security, business teams, and external providers to ensure the platform remains compliant and fit for purpose. TASKS & RESPONSIBILITIES 🚀: Define and maintain the validation strategy, intended use, scope, system boundaries, and lifecycle controls for the IAM platform. Prepare, review, and approve validation documentation, including requirements, risk assessments, traceability, test protocols, deviations, and validation reports. Define risk-based testing approaches covering identity and account management, roles and access rights, access requests and reviews, interfaces, audit trails, reporting, and security controls. Assess changes, releases, cloud updates, incidents, configuration changes, and integrations for GxP impact and determine validation and regression testing requirements. Manage validation deviations and CAPAs, supporting investigations, corrective actions, follow-up, and closure. Maintain the platform in a validated state through change and incident management, periodic reviews, supplier oversight, backup and recovery, archiving, and system retirement. Clarify responsibilities and data ownership across IAM platforms, source systems, workflows, connected applications, and service providers. Collaborate with Quality, System and Process Owners, technical teams, business experts, and suppliers to address risks and implement sustainable solutions. Represent IAM Validation during audits, self-inspections, regulatory inspections, and management reviews. Identify compliance gaps and opportunities to simplify or automate validation and assurance activities. SKILLS 🤹: Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or a related field, or equivalent professional experience. Several years of experience in Computerized System Validation (CSV), Computer Software Assurance (CSA), Quality IT, or validation of global systems supporting GxP processes. 3+ years of experience working in a regulated GxP environment. Strong knowledge of GAMP 5, Data Integrity, EU GMP Annex 11, and FDA 21 CFR Part 11. Hands-on experience with validation documentation, risk assessments, traceability, testing, objective evidence, and validation reports. Strong understanding of IAM processes, including identity and account management, roles and access rights, access requests and reviews, and audit trails. Experience assessing system changes, incidents,…