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.

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 Qualifications

Must-Have:

- 10+ years of experience in Computer System Validation (CSV) within 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).

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 For

We 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 Deliverables

- Medicine 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)

- Hybrid

CONDITIONS :

- Salary package based on your profile.

- 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.

Our goal is that you are well in every way!

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