CSV Project Manager

We are seeking an experienced Computer System Validation (CSV) Project Manager to lead and support validation initiatives across regulated IT systems.

Key Responsibilities:

• Lead end-to-end Computer System Validation (CSV) efforts in IT projects
• Define and execute validation plans, risk assessments, and test strategies in compliance with GxP and internal policies
• Manage documentation throughout the system lifecycle (URS, FRS, IQ, OQ, PQ, etc.)
• Coordinate with QA, IT, and business stakeholders to align on validation deliverables and timelines
• Serve as the primary point of contact for CSV audits, inspections, and compliance reviews
• Oversee the development and review of SOPs, technical documentation, and training materials
• Ensure projects are executed following GAMP 5, Annex 11, and Part 11 guidelines
• Track and report on project progress, risks, milestones, and validation status
• Collaborate with vendors and service providers to ensure validation requirements are met
• Contribute to continuous improvement of validation templates, procedures, and project governance

Requirements:

Must-Have Skills:

• Strong expertise in Computer System Validation (CSV) and GxP-regulated environments
• Proven experience managing IT or validation projects from initiation to completion
• In-depth knowledge of GAMP 5, Annex 11, 21 CFR Part 11, and related compliance standards
• Experience with project planning, documentation tracking, and stakeholder coordination
• Excellent writing skills for producing and reviewing validation documentation
• Familiarity with IT systems in pharma, biotech, or medical environments
• Ability to work independently and collaboratively with cross-functional teams

Nice-to-Have:

• Experience with tools like HP ALM, TrackWise, Veeva, or similar validation platforms
• Background in Quality Assurance or IT Compliance
• Experience with agile methodologies in a regulated context
• Fluency in French or Dutch is a plus