• Develop, implement, and continuously refine risk-based CSV strategies for both off-the-shelf and custom-developed software, ensuring alignment with FDA, EMA, GCP, and ICH guidelines. • Oversee the full lifecycle of validation activities, including planning, execution, documentation, and maintenance, with a focus on integrating CSV into agile software development processes. • Ensure validation deliverables such as risk assessments, validation plans, protocols, test cases, and traceability matrices are prepared to the highest standards of quality and regulatory compliance. • Monitor and interpret changes in global regulatory requirements, proactively updating internal policies and procedures to maintain compliance and operational excellence. • Utilize technology to drive operational efficiencies into the CSV process. • Serve as the subject matter expert on regulatory requirements for computerized systems supporting clinical research, providing guidance on the practical application of regulations to diverse technology solutions. • Collaborate closely with Quality to identify, assess, and remediate compliance gaps, ensuring all systems meet GCP and other relevant standards. • Lead the preparation and submission of documentation for regulatory inspections, audits, and sponsor audits, ensuring timely and accurate responses to findings and observations. • Act as a strategic partner to corporate IT, Product, software development, Quality, and operational teams, facilitating the integration of CSV requirements into business processes and technology projects. • Advocate for pragmatic, risk-based approaches that balance regulatory compliance with business agility and innovation. • Design and deliver training programs to build organizational capability in CSV principles, regulatory requirements, and best practices. • Lead, mentor, and develop a team of validation specialists, fostering a culture of collaboration, accountability, and continuous improvement. • Ensure the team is appropriately resourced, trained, and equipped to deliver on validation objectives and support organizational growth. • Conduct regular performance reviews, set clear goals, and provide constructive feedback to support professional development and high performance. • Represent the CSV function during internal and external audits, regulatory inspections, and sponsor reviews. • Coordinate the investigation and resolution of audit findings, ensuring corrective and preventive actions are implemented effectively and sustainably. • Maintain readiness for audits by ensuring documentation, processes, and systems are consistently compliant and up to date.