Senior Validation Manager | Hybrid (Pharma)

Ambit Iberia; Sant Cugat del Vallès; Ibrido; EUR 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Ticket restaurant

Medical insurance

Public transport ticket

Childcare check

Gym discounts

Training catalogue

Hybrid schedule

Descrizione del lavoro

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.

Competenze

• 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).

Mansioni

• 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.

Descrizione del lavoro

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!