Our client, a leading biopharmaceutical organization, is seeking a strategic professional to lead their computerized system validation governance. The project involves acting as a corporate process owner to ensure oversight, compliance, and continuous improvement of validation processes across a global GxP environment.

• Define the annual strategy and priorities for computerized system validation and access management.
• Map existing standard operating procedures to identify gaps and develop new governance documents and templates.
• Assess the impact of evolving regulations such as new GMP Annexes and the AI Act on internal validation processes.
• Lead discussions with quality assurance and validation teams to ensure organizational alignment.
• Manage inspection readiness and oversee documentation and training requirements for the CSV stream.
• Contribute to active initiatives regarding artificial intelligence validation and Computer Software Assurance updates.
• Act as the primary point of contact for regulatory intelligence and complex validation process questions.