Computer System Validation Coordinator

About the Role The Computer System Validation (CSV) Coordinator – Global Sales is responsible for coordinating and supporting CSV activities across Global Sales. The role ensures validated status and ongoing compliance of computerized systems by maintaining the Validation Master Plan (VMP), coordinating periodic reviews, updating CSV documentation, and providing SME guidance to SSUs. The role is part of the Global Sales QRC team and works in close matrix collaboration with the Group IT CSV organization, including participation in CSV forums, peer reviews, and alignment on standards and templates. What You'll Do

• Coordinate and oversee Computer System Validation (CSV) activities within Global Sales, ensuring alignment with QMS requirements and applicable global standards.
• Maintain, update, and support execution of the Global Sales Validation Master Plan (VMP) with SSUs.
• Establish and maintain an accurate and up-to-date inventory of computerized systems used across Global Sales.
• Monitor, track, and follow up validation and system periodic review status.
• Provide guidance to SSUs for execution of required validation and Periodic Review activities.
• Ensure outcomes, gaps, and actions from validation and periodic reviews are appropriately documented and followed up.
• Support SSUs for compliant and complete retirement of any computer systems via CSV procedures.
• Act as a CSV Subject Matter Expert, providing practical guidance and support to SSUs on CSV validation and System Periodic Review activities.
• Develop and deliver CSV process trainings to SSUs to support consistent understanding and application of CSV requirements.
• Review, update, and continuously improve CSV procedures, work instructions, and templates to enhance usability, clarity, and compliance to related standards and regulations.
• Support harmonized implementation of CSV documentation practices across Global Sales.
• Support global changes and projects impacting Global Sales computerized systems and the QMS (e.g., SAP GShape) from a Quality & Regulatory Compliance perspective.
• Participate in and support corporate and external audits related to Global Sales, including preparation, responses, and follow-up actions.
• Support, coordinate and handle any other project/task given by direct manager for Quality and Regulatory Compliance activities. What We're Looking For
• Strong knowledge of CSV, validation lifecycle, VMP, and System Periodic Review processes.
• Experience coordinating validation activities across business units and with IT, in a Global Sales or commercial environment.
• Ability to develop, deliver, and maintain CSV trainings and supporting documentation.
• Excellent documentation, traceability, and CAPA-follow-up capabilities.
• Experience supporting audits/inspections and responding to audit findings.
• Strong written and verbal communication skills and ability to operate in a matrix organization.
• Familiarity with QMS alignment and regulatory standards relevant to computerized systems (e.g., GMP/cGMP).