Amanda Bertram

Background

About Amanda Bertram

Senior Director, Lifecycle Management – GxP Quality Management System (QMS) Global Quality Organization | Bristol Myers Squibb (BMS) I lead the Lifecycle Management pillar of BMS’s GxP Quality Management System, overseeing procedural documentation, change control, and deviation management across global R&D operations. With over 5 years of experience building and scaling a global QMS, I’ve developed a strong network of 100+ Global Process Owners who manage 45+ critical R&D processes—from Protocol Development and Regulatory Engagement to Clinical Operations. I’ve served as a strategic leader on multi-million-dollar, enterprise-wide initiatives, driving innovation and compliance through AI-enabled solutions with a sharp focus on user experience. My approach to procedural document development is grounded in a deep understanding of health authority expectations, ensuring inspection-readiness and operational clarity. I also lead a high-performing team of quality assurance and procedural writers responsible for the R&D Lifecycle Management Book of Work across the enterprise. My background spans pharmacovigilance, risk management, project management (PMI-Agile Certified), clinical research, quality auditing, and product quality—with a passion for simplification, continuous improvement, and scalable systems that support global innovation.