Senior Validation Leader - Data Platform & RBQM (Hybrid)

Ambit Iberia; Sant Cugat del Vallès; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Ticket restaurant

Medical insurance

Public transport ticket

Childcare check

Gym discounts

Training catalogue

Hybrid schedule

Job summary

Ambit Iberia in Spain is seeking an experienced Senior Validation Manager to lead the validation strategy for the Medicine Data Foundation (MDF) and to stand up the Risk-Based Quality Management (RBQM) initiatives. You will drive validation plans, risk assessments, and traceability across data platforms and complex analytics environments.

The role requires deep CSV and GxP expertise, with a track record of guiding validation activities across the full system lifecycle.

Qualifications

• 10+ years of CSV experience in the pharmaceutical, biotechnology, or regulated healthcare industry.
• Strong knowledge of GxP regulations, validation methodologies, and compliance requirements.
• Proven experience defining validation strategies for complex enterprise systems or platforms.
• Extensive experience leading validation activities throughout the full system lifecycle.
• Strong stakeholder management, communication, and leadership skills.
• Fluent English (written and spoken).

Responsibilities

• Define and lead the validation strategy for the Medicine Data Foundation (MDF).
• Develop and maintain Validation Plans, Validation Assessments, Validation Reports, and associated validation documentation.
• Apply risk-based validation methodologies aligned with GxP requirements and industry best practices.
• Assess platform capabilities, controls, data flows, and validation scope/boundaries.
• Ensure end-to-end traceability between business requirements, system functionality, risk assessments, testing activities, and validation evidence.
• Support the validation needs of the RBQM initiative as the first strategic consumer of MDF data products.
• Collaborate closely with Quality, IT, Data & Analytics teams, Product Owners, Solution Architects, and Business stakeholders.
• Manage validation-related risks, deviations, CAPAs, and inspection readiness activities.
• Provide expert guidance on CSV, Data Integrity, and regulatory compliance.
• Contribute to the creation of reusable validation frameworks, standards, and assets for future data platforms and data products.

Job description

Ambit Iberia in Spain is seeking an experienced Senior Validation Manager to lead the validation strategy for the Medicine Data Foundation (MDF) and to stand up the Risk-Based Quality Management (RBQM) initiatives. You will drive validation plans, risk assessments, and traceability across data platforms and complex analytics environments.

The role requires deep CSV and GxP expertise, with a track record of guiding validation activities across the full system lifecycle.