At Ambit, we are looking for an experiencedSenior Validation Managerto join a strategic initiative within a leading global pharmaceutical company.The successful candidate will play a key role in the validation of theMedicine Data Foundation (MDF), a next-generation data platform designed to enable data-driven decision-making across the Medicine domain. The first major use case supported by MDF will be theRisk-Based Quality Management (RBQM)initiative, making this a unique opportunity to contribute to the validation of modern data products in a highly regulated environment.This role is ideal for professionals with extensive experience inComputer System Validation (CSV), strong knowledge ofGxP regulations, and a background in validating complex data, analytics, or cloud-based platforms within the pharmaceutical industry.Key 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.Required QualificationsMust-Have:10+ years of experience inComputer System Validation (CSV)within the pharmaceutical, biotechnology,



or regulated healthcare industry.Strong knowledge ofGxP 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).Nice-to-Have:Experience validating Data Platforms, Data Lakes, Data Warehouses, or Analytics solutions.Knowledge of Microsoft Azure, Microsoft Fabric, or other modern cloud-based architectures.Familiarity with Data Products, Data Mesh, and enterprise data platform concepts.Experience supporting Clinical Development, Medicine, Quality, Regulatory Affairs, or R&D data initiatives.Exposure to Risk-Based Quality Management (RBQM), Central Monitoring, Clinical Data Analytics, or related disciplines.Experience with Veeva or other Life Sciences digital platforms.What We Are Looking ForWe are seeking a senior consultant who combines:Deep expertise in CSV and GxP validation.Strong understanding of modern data and analytics ecosystems.Experience within the pharmaceutical or life sciences industry.Strategic mindset with the ability to define scalable validation approaches.Excellent communication and stakeholder engagement capabilities.Expected DeliverablesMedicine Data Foundation Validation Strategy.Validation Plan and Risk Assessment.Traceability Framework.Validation Execution Oversight.Audit and Inspection Readiness Support.Reusable Validation Assets for future Data Products.Validation Support for RBQM implementation.SCHEDULE:08h-17h from Monday to Friday (flexible)HybridCONDITIONS:Salary package based on your profile.Permanent contractTicket restaurant included in-office hours.Adaptable 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.Our goal is that you are well in every way!#J-18808-Ljbffr

📌 Senior Validation Manager | Hybrid (Pharma) (Madrid)
🏢 Ambit Iberia
📍 Madrid