Deborah Castellana

Bio:

Deborah Castellana has over 15 years of leadership experience in Trial Master File (TMF), Regulatory, and Clinical Document Management within the biopharmaceutical industry. She served as Director of CT Documentation and Archiving at Bristol Myers Squibb (BMS) and has optimized TMF processes and systems, implemented eTMF archival, and ensured compliance with Good Clinical Practices (GCP). Deborah has held key roles at leading pharmaceutical companies including Novartis, Celgene, and Shire, where she has been involved in delivering inspection-ready TMFs, leading teams, integrating TMF from acquired companies, and applying automation to improve operational quality and efficiency. She developed TMF standards and implemented inspection readiness strategies, effectively supporting global inspections and successfully resolving CAPAs. In her leadership and advisory roles, she has established documentation standards, provided technical and quality support, and contributed to global document management and archival practices.