CSV and Data Integrity Manager

To support our continued growth and commitment to world-class quality, we are looking for a CSV and Data Integrity Manager to be the quality lead for digital, computerised and IT-enabled systems, ensuring that appropriate compliance, data integrity, computer systems validation, information security and audit readiness standards are embedded across the business. The role provides independent quality oversight of computerised systems, data integrity, Computer Systems Validation and information security compliance, ensuring that appropriate methodologies, governance, quality risk management controls, metrics and escalation routes are in place.

Key Responsibilities

• Act as the Quality lead for eCompliance, data integrity, Computer Systems Validation and information security compliance across relevant systems and processes. Ensure appropriate methodologies, standards and procedures are developed, maintained and embedded within the Quality Management System.
• Provide Quality oversight throughout the computer-system lifecycle, including scoping, vendor selection, implementation, validation, go-live, routine operation, change control and periodic review. Ensure systems are compliant, robust, practical to operate and supported by appropriate lifecycle documentation.
• Ensure data integrity and information security principles are embedded into system design, implementation and operational use. Approve relevant data integrity methodologies, procedures, templates, assessments, remediation plans and change controls for key or critical systems.
• Review and approve key validation and project lifecycle documentation, including validation plans, GxP assessments, data migration plans, functional risk assessments, UAT/PQ test reports, validation reports, data migration reports and go/no-go decisions where appropriate.

Skills, Knowledge & Expertise

• Degree or equivalent in a scientific, technical, quality, compliance, IT, systems or business-related discipline, or equivalent practical experience overseeing computerised systems in a regulated or compliance-led environment.
• Experience in GxP, ERES, pharmaceutical, chemical, manufacturing, life sciences or another highly regulated environment.
• Experience of Computer Systems Validation, system lifecycle documentation, change control and periodic review in a regulated or compliance-led environment.
• Experience of managing or supporting regulatory inspections, customer audits or formal compliance audits. Strong understanding of data integrity expectations and how these apply to computerised systems and operational processes.
• High level of technical ability, able to understand system architecture, access controls, data flows, back-up arrangements, resilience requirements and system-change implications.
• Strong stakeholder-management skills, with the confidence to influence across Quality, IT and operational teams.
• Strong written and verbal communication skills, including the ability to prepare audit material, policies, reports and senior-management updates.
• Pragmatic and solutions-focused, with the ability to balance compliance requirements with operational practicality.
• Formal training or qualification in auditing, validation, Quality Management, Computer Systems Validation, GxP, IT governance, data integrity or information security would be beneficial.