• Lead IT compliance initiatives ensuring adherence to world-wide regulatory authorities, GLP, GCP, and other applicable regulations and standards (e.g., 21 CFR Part 11, 820, Annex 11, OECD 22). • Manage and execute validation of cloud-based and hosted applications, including risk assessments, validation planning, IQ/OQ/PQ testing, and traceability documentation. • Primary owner of the system development lifecycle and CSV process and policies and procedures for such. • Oversee the new system implementation process and IT change management process. • Develop, review, and maintain key compliance and SDLC documents such as validation protocols, test scripts, SOPs, configuration management, change control, and system release documentation. • Prepare and lead IT-related activities for FDA, UK, EU and other regulatory inspections or audits; provide expert responses to auditor queries; manage quality events, corrective and preventive actions (CAPAs) resulting from inspections. • Author and maintain IT compliance policies, procedures, and standard operating procedures (SOPs) to ensure consistent, regulatory-aligned practices across systems and teams. • Partner with IT infrastructure, cybersecurity, QA, and business system owners to ensure alignment of compliance and validation activities with business needs. • Evaluate and enhance IT validation and compliance processes for efficiency and scalability in support of digital transformation and cloud adoption. • Take Quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for the projects that include new implementation, enhancements, quarterly releases, periodic reviews, review and approve Quality events (deviations & CAPS), etc. • Participate and drive system assessments, review and approve the project deliverables, including plan, test scripts, execution and its outcome, reports, and traceability. • Actively participate in and guide discussions to resolution, adhering to all quality standards.