Validation Manager for Holistic Data Management Project | 100% remote | Pharma

Ambit Iberia; Sant Cugat del Vallès; Remote; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Public transport ticket

Childcare support

Gym discounts

Training catalogue

Referral program

Job summary

Ambit Iberia is seeking a Validation Manager to lead validation activities for a Holistic Data Management initiative within a global pharmaceutical environment. You will ensure that systems meet CSV, GxP, GLP standards across their lifecycle.

The role collaborates with Business stakeholders, IT System Leads, QA, CSV & Compliance teams, and System Owners to support validation approvals and compliance-related activities, including audits and inspections.

Qualifications

• Strong knowledge of CSV principles and methodologies.
• Familiarity with FDA 21 CFR Part 11, EU GMP Annex 11, GxP requirements.
• Experience in preparing validation documentation in regulated environments.
• Understanding of validated IT systems, software, infrastructure, and integrations.
• Excellent analytical, documentation, and stakeholder management skills.

Responsibilities

• Own and coordinate all validation activities for the system.
• Prepare, review, and maintain Validation Plans, Test Documentation, Traceability Matrices, and Validation Summary Reports.
• Lead qualification activities across QA and Production environments.
• Coordinate validation testing activities, deviation management, and defect resolution.
• Ensure compliance with CSV, GxP, GLP, and applicable validation standards.
• Review and support SOPs, training materials, and go-live documentation.
• Collaborate with Business stakeholders, IT System Leads, Quality Assurance, and System Owners to support approvals.
• Act as a key compliance partner during audits and inspections.

Skills

CSV principles

Regulatory frameworks

Documentation

Stakeholder management

Audits & inspections

Education

Bachelor's degree in IT/Life Sciences/Healthcare or related field

Job description

Hybrid | Pharmaceutical Industry

Are you passionate about Computer System Validation (CSV) and ensuring compliance in regulated environments? We are looking for a Validation Manager to lead validation activities for a strategic Holistic Data Management (HDM) initiative within a global pharmaceutical environment.

What You'll Do

As Validation Manager, you will be responsible for ensuring that the system meets all applicable validation and compliance requirements throughout its lifecycle.

Key responsibilities include:

• Own and coordinate all validation activities for the system.
• Prepare, review, and maintain validation documentation, including Validation Plans, Test Documentation, Traceability Matrices, Validation Summary Reports, and related records.
• Lead qualification activities across QA and Production environments, ensuring release readiness.
• Coordinate validation testing activities, deviation management, and defect resolution.
• Ensure compliance with CSV, GxP, GLP, and applicable validation standards.
• Review and support SOPs, AAPs, training materials, and operational documentation required for go-live.
• Collaborate with Business stakeholders, IT System Leads, Quality Assurance, CSV & Compliance teams, and System Owners to support validation approvals and compliance-related activities.
• Act as a key compliance partner during audits, inspections, and system lifecycle activities.

Must-Have Requirements

• Bachelor's degree in Information Technology, Healthcare, Life Sciences, or a related field.
• Strong knowledge of Computer System Validation (CSV) principles and methodologies.
• Expert understanding of regulatory frameworks and guidance, including:
  • FDA 21 CFR Part 11
  • EU GMP Annex 11
  • GxP requirements and validation best practices
• Experience preparing and maintaining validation documentation in regulated environments.
• Solid understanding of validated IT systems, including software, infrastructure, and system integrations.
• Strong analytical, documentation, and stakeholder management skills.

Nice to Have

• More than 3 years of experience in Computer System Validation within the pharmaceutical, biotechnology, or life sciences industry.
• Experience supporting complex data management, digital transformation, or enterprise applications.
• Previous exposure to audit and inspection readiness activities.
• Experience working within global, cross-functional teams.

SCHEDULE:

• 08h-17h from Monday to Friday (flexible)
• Full remote

CONDITIONS:

• Salary package based on your profile.
• Permanent contract
• 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.
• Referral program

Our goal is that you are well in every way!