CSV Governance Lead - CSV Digitalization Project

Pauwels Consulting; Eigenbrakel; On-site; EUR 90,000 - 130,000; Full time

Job summary

Pauwels Consulting is seeking a senior professional to lead the digitalization of validation processes for a leading biopharmaceutical client. The role focuses on translating governance processes into digital workflows while ensuring compliance and operational efficiency for the project.

Responsibilities include implementing a validation management module, translating governance constructs into workflows, and guiding system validation activities with technical teams.

Qualifications

• 8+ years of CSV and Information Systems validation experience.
• Expertise in Computer System Validation governance and validation processes.
• Ability to translate business requirements into system requirements.
• Strong analytical mindset with technical savviness.
• Excellent communicator able to challenge processes and drive improvements.
• Fluent in English.

Responsibilities

• Drive digitalization of validation processes by implementing and rolling out a validation management module.
• Translate governance processes into efficient digital workflows.
• Define validation requirements and support system validation activities with technical developers.
• Review user feedback and requirements to ensure system functionality meets business needs.
• Challenge existing processes to drive continuous improvement and digitalization of governance frameworks.
• Manage stakeholders across the organization, including project managers, system owners, and validation experts.

Skills

CSV/IS validation

CS Validation governance

Requirements translation

Analytical thinking

Communication

English language

Tools

Veeva

Job description

Our client, a leading biopharmaceutical company, is looking for a senior professional to lead the digitalization of validation processes. This role focuses on translating governance processes into digital workflows while ensuring compliance and operational efficiency for the project.

• Drive the digitalization of validation processes through the implementation and rollout of a validation management module.
• Translate complex governance processes into efficient digital workflows.
• Define validation requirements and support system validation activities in collaboration with technical developers.
• Review user feedback and requirements to ensure system functionality meets business needs.
• Challenge existing processes to drive continuous improvement and digitalization of governance frameworks.
• Manage stakeholders across the organization, including project managers, system owners, and validation experts.

• You have 8+ years of relevant experience in CSV and Information Systems validation.
• You possess deep expertise in Computer System Validation (CSV) governance and validation processes.
• You bring a proven ability to translate business requirements into system requirements within project environments.
• You have a strong analytical mindset and technical savvy, allowing you to comfortably work with complex systems.
• You're an excellent communicator with the ability to challenge processes and drive improvements.
• You are fluent in English.

Nice to Haves

• Experience with Veeva systems and digitalization or business transformation projects.
• Background as a Process Owner, Governance Lead, or Business Analyst with additional IT knowledge.
• Proficiency in French.