Emma Ramnarine is Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes. This initiative is sponsored by Chief Quality Officers of 20+ global pharma companies who have decided to speak with a unified voice, and develop standard solutions to reduce global PAC complexity.
Emma has 20+ years of global experience in the pharmaceutical, biotechnology and medical device industries in Analytical Science & Technology, Risk Management, Quality Control and Quality Management Systems. She is currently on the PDA Board of Directors and has led several PDA Task Forces and Technical Reports (TR) including a series of TRs on “Implementation of Quality Risk Management” and “Risk Based Approach for Prevention and Management of Drug Shortages”.
Emma is currently Global Head of External Development Collaborations at Genentech/Roche, managing the external network for development, manufacturing, and clinical collaborations of Roche’s Biologics and Small Molecules development portfolio. Prior to this, she was the Global Head of Analytical Science and Technology at Genentech/Roche, providing strategic direction and leadership for product control systems lifecycle management, analytical technology innovation and tech transfers. She is also a worldwide-recognized expert on Quality Risk Management (QRM), and continues to provide QRM training to regulatory authorities and at industry forums.
She holds an M.S. in Pharmaceutical Sciences from the University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India. She is currently pursuing her PhD in Pharmaceutical Sciences from Technological University Dublin; her research focuses on this topic of transforming PAC management to solve the continual improvement and innovation challenge in the pharmaceutical industry.