Debbie N. Cote, RN
Senior Consultant, Clinical Operations, GXP Quality Assurance and Project Management
Debbie is an experienced clinical leader with over 30 years of experience driving global drug and
medical device development. As a specialist in GXP Quality Assurance, she provides the
strategic oversight and project management necessary to ensure clinical programs meet the
highest regulatory standards. Her expertise focuses on the rigorous execution of GCP, GMP,
and GLP site and vendor audits, providing clients with the confidence and data integrity
required for successful BLA, NDA, and MAA submissions.
Formerly a neurological critical care RN and an executive leader at Janssen (J&J), Apexigen
and Eureka Therapeutics, etc. Debbie bridges the gap between clinical complexity and
regulatory compliance. She excels at designing scalable Quality Management Systems (QMS).
managing high-value vendor partnerships, and leading "inspection-ready" clinical DevOps for
high-stakes programs in neuroscience, oncology, and rare diseases. A recognized thought
leader in trial optimization, Debbie is dedicated to mitigating risk and accelerating the delivery
of life-changing therapies to patients.