<p>Responsibilities</p> <ul> <li>Lead the global CSV team, providing guidance, training, and support to ensure the successful execution of validation activities. </li><li>Provides IT CSV oversight for GXP computerized systems and risk-based applications to validation/qualification efforts in compliance with 21 CFR Part 11, GMP Annex 11, OECD 17 and GAMP 5. </li><li>Provides IT CSV oversight of deviations, CAPAs, and change controls related to GXP computerized systems. </li><li>Review and create validation documentation - such as user requirements functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments and traceability matrices, and validation summary reports. </li><li>Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure the successful validation of computer systems and software applications. </li><li>Effectively identifies and resolves system issues and appropriately communicates gating items to senior management and stakeholders. </li><li>Supports the external audit program for vendors related to GXP computerized systems. </li><li>May support and interface with regulatory agencies as required in support of regulatory agency inspections. </li><li>Develop and implement CSV strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g., FDA, MHRA, NMPA and TGA). </li><li>Review and approve validation documentation, ensuring accuracy, completeness, and compliance with regulatory requirements. </li><li>Effectively resource, coordinate, monitor and track validation activities to ensure timely completion and adherence to project timelines. </li><li>Stay current with industry trends, regulatory changes, and best practices related to CSV. </li><li>Provide support during regulatory inspections and audits, including presenting validation strategies and justification of risk-based decisions taken. Continuously improving the CSV process by identifying areas for enhancement and implementing best practices. </li></ul> <p>Skills, Education & Qualifications</p> <ul> <li>Direct experience of leading or managing CSV projects in GxP environments. </li><li>GLP/GCP experience necessary. GMP experience preferable. </li><li>Experience supporting regulatory inspections. </li><li>B.S. degree in Computer Science, Chemistry or relevant scientific field with substantial relevant progressive experience, within the pharmaceutical/biotech industry. </li><li>Extensive experience in federally regulated industries or CSV teams in Pharmaceutical / Biotech industry with comprehensive expertise and working knowledge of GxP, 21 CFR Part 11, OECD 17, and GMP Annex 11 compliance requirements. </li></ul>