Deborah Gessell-Lee MS, PhD M2DCON

Deborah Gessell-Lee MS, PhD

Deborah Gessell-Lee MS, PhD M2DCON Director of Quality Assurance and Regulatory Compliance

Deborah Gessell-Lee, PhD is a distinguished scientist and accomplished pharmaceutical quality executive, recognized for her exceptional expertise in translating science into practical and sustainable solutions for pharmaceutical and medical device organizations. With a proven track record of success, she has made significant contributions to the advancement of medical device commercialization, spanning research, development, manufacturing operations, facility expansion, quality, and regulatory compliance. Throughout her career, Deborah has held various leadership positions within renowned pharmaceutical and medical device companies. As a quality executive, she has consistently demonstrated an unwavering dedication to maintaining the highest standards of quality and safety in drug product manufacturing processes, pharmaceutical compounding, and medical device manufacturing. Deborah is widely regarded for her exceptional problem-solving skills and ability to implement innovative strategies to optimize quality. Her strong analytical mindset and scientific acumen enable her to identify potential bottlenecks, mitigate risks, and improve efficiency in production processes. She is known for their outstanding leadership skills, fostering collaboration among cross-functional teams, and driving impactful change within organizations. And, along the way, Deborah also became a Patient Safety Centric Professional with a passion for aseptic operations and all things microbiology!