Validation Manager for Holistic Data Management Project | 100% remote | Pharma
At Ambit Iberia · Sant Cugat del Vallès, Spain
- DevOps and infrastructure
- Full-time
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Open to Spain
“Sant Cugat del Vallès, Spain”
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- Posted
- 5 November 2026
- First seen by us
- 6 November 2026
- Last checked
- 13 hours ago
Job description
From Ambit Iberia’s job post, as they wrote it.
📍 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.
Read the full description
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!
Validation Manager for Holistic Data Management Project | 100% remote | PharmaAmbit Iberia
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