IAM Validation Specialist | Pharma (Hybrid)

Ambit Iberia; Sant Cugat del Vallès; Hybrid; EUR 65,000 - 95,000; Full time

Benefits offered by this job

Restaurant tickets

Medical insurance

Gym discounts

Job summary

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

You will blend Computerized System Validation with IAM knowledge across the full lifecycle, defining validation strategies, risk-based testing, and oversight of deviations and CAPAs. Strong collaboration with QA, IT, Security, and suppliers is essential.

Qualifications

• Degree in Computer Science, Engineering, Life Sciences, or related field.
• 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.
• 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.

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

CSV/CSA

GxP validation

IAM processes

Regulatory compliance

Communication

Analytical thinking

Risk assessment

GAMP 5

Regulatory audits

English fluency

Education

Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field

Tools

SailPoint Identity Security Cloud

Microsoft Entra ID

ITIL tools

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.

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, 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!