Remote IAM Validation Specialist for GxP Pharma

Ambit Iberia

Barcelona

Hybrid

EUR 70,000 - 100,000

Full time

2 days ago
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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

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.

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