IAM Validation Specialist | Pharma (Hybrid)

Ambit Iberia; Barcelona; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Ticket restaurant

Medical insurance

Public transport ticket

Childcare support

Gym discounts

Training catalogue

Job summary

Ambit Iberia is seeking an IAM Validation Manager to ensure validated state, compliance, and quality of an Identity & Access Management platform supporting GxP processes in a regulated pharmaceutical environment.

You will define validation strategy, prepare documentation, and manage risk-based testing across identity management, access reviews, and audit trails. Hybrid schedule with 4 days remote and 1 day in-office.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or 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 in a regulated GxP environment.

Responsibilities

• Define and maintain the validation strategy, scope, and lifecycle controls for the IAM platform.
• Prepare, review, and approve validation documentation including requirements, risk assessments, traceability, tests, deviations, and validation reports.
• Define risk-based testing approaches covering identity and access management, roles, access reviews, interfaces, audit trails, and security controls.
• Assess changes, releases, cloud updates, incidents, configurations, and integrations for GxP impact and determine validation/testing needs.
• Manage validation deviations and CAPAs, supporting investigations and closure.
• Maintain the platform in a validated state through change and incident management, periodic reviews, supplier oversight, backup/recovery, archiving, and retirement.
• Clarify responsibilities and data ownership across IAM platforms and connected systems.
• 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, inspections, and management reviews.
• Identify compliance gaps and opportunities to simplify or automate validation and assurance activities.

Skills

IAM processes

GxP validation

GAMP5

Data Integrity

FDA 21 CFR 11

Quality IT

Risk assessment

Documentation

Communication

Regulatory interviews

Education

Bachelor’s or Master’s degree in CS/Engineering/Life Sciences

Job description

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.
• Flexible 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!