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