Donna Walters
About Donna Walters
Donna Walters is the Sr. Director of R&D Lifecycle Management and QMS Documentation at Bristol Myers Squibb, with over 25 years of experience in clinical science and operations.
Current Position at Bristol Myers Squibb
Donna Walters currently serves as the Sr. Director of R&D Lifecycle Management, QMS Documentation at Bristol Myers Squibb. She is based in Lawrenceville, New Jersey, United States. In this role, she is responsible for overseeing the entire lifecycle management of research and development documentation within the company's quality management systems (QMS). Her work involves ensuring compliance with regulatory standards and optimizing processes to facilitate efficient documentation management.
Past Experience at Covance
Donna Walters has a rich history of experience at Covance, where she held multiple roles. From 2019 to 2020, she served as the Director of Controlled Procedural Documents (Quality Assurance and Compliance). Prior to that, she was the Associate Director of Regulatory Policy, Compliance, and Standards from 2015 to 2020 in Princeton, NJ. In these roles, she focused on maintaining compliance with regulatory standards, managing quality assurance practices, and developing standardized procedural documents.
Roles at Merck
Donna Walters worked at Merck in various capacities over a span of 12 years. From 2006 to 2010, she was the Director of Document Management and Trial Registration. Before that, she served as Associate Director, Medical Program Documentation Specialist (MPDS) /Manager, MPDS from 2002 to 2006. Additionally, she held the role of Clinical Associate/Sr. Medical Program Coordinator/Medical Program Coordinator from 1991 to 2002. During her tenure at Merck, she was instrumental in managing clinical documentation and registration processes, ensuring compliance, and coordinating medical programs.
Educational Background
Donna Walters holds a Bachelor of Arts (BA) in Biology from the University of Delaware, where she studied from 1979 to 1983. Her background in biology laid the foundation for her extensive career in clinical science and regulatory compliance. Alongside her academic qualifications, she also holds a Six Sigma Executive Belt certification, which demonstrates her expertise in process optimization and quality management.
Skills and Specializations
Donna Walters specializes in various aspects of clinical science and operations. Her expertise includes people management, project and staffing allocation/capacity planning, compliance/regulatory management, start-up and turnaround operations, and CRO relationship management. She is also adept in organizational management, change and transition management, and process creation and re-engineering. Her broad skill set allows her to effectively collaborate with cross-functional and outsource teams to achieve project goals.