Stelios Tsinontides PhD, FAIChE Merck & Co., Inc.

Dr. Stelios Tsinontides is Vice President of Global Quality, Merck & Co., Inc. He is the Head of Quality Management Systems, Transformation and External Advocacy for Merck Manufacturing Division globally. Prior to joining Merck & Co., Dr. Stelios Tsinontides served as Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA) under the Office of Pharmaceutical Quality (OPQ) in CDER from October 2019 to March 2025. OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at commercial scale and provides leadership and technical expertise to Agency components internal and external to the Office of Pharmaceutical Quality regarding manufacturing quality issues. Prior to joining the FDA, Dr. Tsinontides served in senior-level positions in the pharmaceutical industry - most recently as Shire’s Head of Small Molecule Drug Product Technical Services. His group was responsible for providing scientific and technical expertise for SM Drug Product scale-up and commercial manufacturing activities worldwide, to ensure the establishment of commercial robust manufacturing processes and a continuous supply of products to patients. Dr. Tsinontides holds a B.E. in Chemical Engineering from City College of CUNY and an M.A. and Ph.D. in Chemical Engineering from Princeton University. He also attended the Wharton Management Program at the University of Pennsylvania. Dr. Tsinontides was elected Fellow at the American Institute of Chemical Engineering (AIChE) in 2016.