Senior Validation Manager | Hybrid (Pharma)

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.
• Flexible 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!