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.

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, integrations, and releases from a GxP validation perspective.
- Strong analytical and risk-based decision-making skills.
- Ability to translate regulatory requirements into practical, proportionate, and testable controls.
- Excellent communication skills, with the ability to explain complex validation topics to technical and non-technical stakeholders.
- Fluent English, both written and spoken.

Nice To Have

- Experience with IAM or Identity Governance platforms such as SailPoint Identity Security Cloud, Microsoft Entra ID, or similar.
- Knowledge of Cloud and SaaS operating models, including supplier responsibilities, APIs, interfaces, and shared controls.
- Familiarity with IT Service Management and ITIL principles.
- Experience working with Agile delivery methodologies.
- Familiarity with tools for document management, testing, or validation support.
- Previous involvement in audits or regulatory inspections.

Schedule

- 08h-17h from Monday to Friday (flexible)
- 4 days by remote, 1 day office work (every thursday)

Conditions

- Salary package based on your profile.
- Ticket restaurant included in office hours.
- Versátil compensation plan (free of income tax) where we provide you with medical insurance, public transport ticket and childcare check.
- Discounts in gym network.
- Training catalogue.

Our goal is that you are well in every way!

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📌 IAM Validation Specialist | Pharma (Hybrid) (Barcelona)
🏢 Ambit Iberia
📍 Barcelona