At Ambit, we are looking for an experienced Senior Validation Manager to join a strategic initiative within a leading global pharmaceutical company. The successful candidate will play a key role in the validation of the Medicine 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 the Risk-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 in Computer System Validation (CSV) , strong knowledge of GxP regulations , and a background in validating complex data, analytics, or cloud-based platforms within the pharmaceutical industry. Define and lead the validation strategy for the Medicine Data Foundation (MDF). 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. 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. Fluent English (written and spoken). 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. We are seeking a senior consultant who combines: Strong understanding of modern data and analytics ecosystems. Experience within the pharmaceutical or life sciences industry. Medicine Data Foundation Validation Strategy. Reusable Validation Assets for future Data Products. 08h-17h from Monday to Friday (flexible) ~ Hybrid Permanent contract Ticket 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.

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