Validation Manager for Holistic Data Management Project | 100% remote | Pharma
Company: Ambit Iberia
- Location: Sant Cugat del Vallès, Spain
- Work mode: Remote
- Posted: Yesterday
- Offer language: English
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!
