Senior Product Owner - CSV

The Senior Product Owner - CSV is responsible for leading and managing Computer System Validation (CSV) activities to ensure digital systems are compliant, validated, and fit for purpose throughout their lifecycle.

Key Responsibilities:

• Manage CSV requirements, validation deliverables, and compliance activities for MES systems.
• Own and manage CSV requirements, validation activities, risk assessments, testing, change controls, and release readiness to ensure 100% compliance with GxP, data integrity, security, and regulatory requirements.
• Ensure on-time delivery of validation documentation, test evidence, and approvals, maintain systems in a validated and audit-ready state throughout their lifecycle.
• Drive audit and inspection readiness, minimizing compliance observations and ensuring timely closure of audit findings, deviations, CAPAs, and change controls.
• Collaborate with business, quality, engineering, and site teams to deliver validated solutions that meet business objectives and regulatory expectations.
• Contribute to product roadmap planning and backlog prioritization, ensuring delivery aligns with compliance, operational, and business priorities.
• Monitor and improve key metrics including validation cycle time, compliance status, release readiness, system availability, roadmap delivery, and stakeholder satisfaction.
• Lead continuous improvement, standardization, and adoption of CSV best practices to increase efficiency, consistency, and compliance across MES platforms.
• Leverage AI and automation to improve validation efficiency, documentation quality, test execution, and compliance monitoring.
• Ensure systems remain reliable, compliant, available, and fit for purpose, supporting operational continuity and business performance.

Basic Qualifications:

• Bachelor’s or master’s degree in computer science, Information Technology, Engineering, Business, Life Sciences or a related discipline, or equivalent relevant experience.
• Minimum 2–4 years of experience in CSV, validation, quality, business analysis or technology delivery within regulated manufacturing environments.
• Experience in managing CSV deliverables, including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Traceability Matrices, Test Protocols (IQ/OQ/PQ/UAT) Installation / Operational / Performance Qualification/User Acceptance Testing, Validation Reports and Change Controls.
• Experience in translating business and regulatory requirements into compliant, risk-based MES solutions.
• Experience in collaborating with Quality, Validation, Engineering, IT and business teams to maintain validated and audit-ready systems.
• Experience in GxP, data integrity, security and regulatory requirements, including use of AI and automation tools to support validation activities, documentation, testing and compliance monitoring.
• Experience in working with enterprise MES platforms in GxP-regulated pharmaceutical manufacturing environments.

Preferred Qualifications:

• Experience in communication, facilitation and stakeholder management, including engaging business, quality, IT and validation stakeholders.
• Experience in facilitating requirements gathering, backlog prioritisation and solution reviews with stakeholders.
• Experience in applying analytical decision-making to balance business value, compliance, risk and operational impact.
• Experience in translating business and validation requirements into product priorities and validated solutions.
• Experience in MES, CSV, data integrity, security and GxP compliance requirements.
• Experience in maintaining documentation, traceability and lifecycle management records.
• Experience in working across cross-functional, global and vendor teams in a collaborative way.
• Experience in delivering solutions that meet compliance, user and business requirements.