Diluks De Silva

Diluks De Silva is a global Quality and Compliance executive with over 25 years of experience across cell and gene therapy, radiopharmaceuticals, and biopharmaceutical manufacturing. He specializes in providing strategic quality and regulatory consulting services to life sciences organizations, with a focus on regulatory strategy, inspection readiness, quality system transformation, and global product launch execution. His expertise spans advanced therapy manufacturing, data integrity, remediation programs, technology transfer, and the development of scalable, compliant quality operating models.

Mr. De Silva has held senior leadership roles at Novartis, where he led global and regional quality organizations supporting complex, multi-site operations. He played a critical role in the first commercial CAR-T manufacturing platform (Kymriah™), enabling global launches across the U.S., EU, and APAC, and supported the successful commercialization of PLUVICTO®, a breakthrough radioligand therapy. Throughout his career, he has partnered closely with executive leadership and global health authorities—including the FDA and EMA—to shape regulatory strategy, drive inspection readiness, and lead remediation efforts in highly regulated environments.

With deep expertise in quality system design, GxP frameworks, and organizational transformation, Mr. De Silva has successfully built and led high-performing quality organizations, supported large-scale manufacturing readiness initiatives, and guided companies through regulatory challenges including FDA 483 responses, warning letter remediation, and global inspection preparedness. He brings a practical, execution-focused approach to helping organizations achieve sustainable compliance, operational excellence, and successful commercialization across the product lifecycle.