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Validation Manager – Holistic Data Management, Pharma
Ambit Iberia. Own and coordinate all validation activities for the system .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Computer System Validation (CSV) principles and methodologies, ensuring compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and GxP requirements. Proficient in preparing and maintaining validation documentation and leading validation activities in regulated environments within the pharmaceutical and life sciences sectors.
Highest-signal resume keywords
Computer System Validation (CSV)FDA 21 CFR Part 11EU GMP Annex 11GxP RequirementsValidation Documentation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation PlansTest DocumentationTraceability MatricesValidation Summary ReportsDeviation ManagementDefect ResolutionAnalytical SkillsDocumentation SkillsStakeholder ManagementData Management
Soft Skills
CollaborationCommunicationLeadership
Tools & Technologies
Validated IT SystemsEnterprise Applications
Industry Keywords
PharmaceuticalBiotechnologyLife SciencesComplianceAudit Readiness
About the role
Key responsibilities & impact- 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
- Lead validation for a global pharmaceutical data management initiative from testing to go-live
Requirements
What you’ll need- 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 FDA 21 CFR Part 11
- Expert understanding of EU GMP Annex 11
- Expert understanding of 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
- 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
- Monday–Friday availability during 08h–17h schedule, with flexibility
Benefits
Comp & perks- Permanent contract
- Flexible compensation plan (free of income tax) including medical insurance, public transport ticket, and childcare check
- Discounts in gym network
- Training catalogue
- Referral program
- Flexible working hours
- Fully remote work