Validation Manager – Holistic Data Management, Pharma

This is a fully remote position, open to applicants in Spain.

📋 Description

• Take ownership and manage all validation activities for the system.

• Create, review, and sustain validation documentation, which includes Validation Plans, Test Documentation, Traceability Matrices, Validation Summary Reports, and related records.

• Oversee qualification activities across Quality Assurance and Production environments to ensure readiness for release.

• Coordinate validation testing activities, manage deviations, and resolve defects.

• Ensure adherence to CSV, GxP, GLP, and relevant validation standards.

• Review and assist with SOPs, AAPs, training materials, and operational documentation necessary for go-live.

• Collaborate with Business stakeholders, IT System Leads, Quality Assurance, CSV & Compliance teams, and System Owners to facilitate validation approvals and compliance-related activities.

• Serve as a key compliance partner during audits, inspections, and system lifecycle activities.

• Lead validation efforts for a global pharmaceutical data management initiative from testing through to go-live.

⛳️ Requirements

• Bachelor's degree in Information Technology, Healthcare, Life Sciences, or a related discipline.

• In-depth knowledge of Computer System Validation (CSV) principles and methodologies.

• Proficient understanding of FDA 21 CFR Part 11.

• Proficient understanding of EU GMP Annex 11.

• Proficient understanding of GxP requirements and validation best practices.

• Experience in preparing and maintaining validation documentation in regulated environments.

• Strong comprehension of validated IT systems, including software, infrastructure, and system integrations.

• Excellent analytical, documentation, and stakeholder management skills.

• Over 3 years of experience in Computer System Validation within the pharmaceutical, biotechnology, or life sciences sectors.

• Experience in supporting complex data management, digital transformation, or enterprise applications.

• Previous experience with audit and inspection readiness activities.

• Experience working within global, cross-functional teams.

• Availability Monday–Friday during an 08h–17h schedule, with flexibility.

🏝️ Benefits

• Permanent contract.

• Flexible compensation plan (free of income tax) that includes medical insurance, public transport ticket, and childcare check.

• Discounts at gym network.

• Access to a training catalogue.

• Referral program.

• Flexible working hours.

• Fully remote work.