Emma Ramnarine is the Sr. Director, Head of Global Analytical Science & Technology at Roche Pharma. She is accountable for the strategic and technical leadership for analytical methods, specifications, and technologies for Roche’s commercial Biologics and Small Molecule products. This includes establishing and maintaining up-to-date, compliant and harmonized analytical control systems, proactive lifecycle management, technology innovation, method transfers, stability program, raw materials, and reference standards management.
She has 17+ years of experience in the pharmaceutical, biotechnology, and medical device industry in QC, Quality System Management, Quality Risk Management (QRM), validation, and change control. She is a worldwide recognized expert on QRM, providing QRM leadership, expertise and training to regulatory authorities, and industry.
Emma has been active with PDA for 15 years in various volunteer and leadership roles. She has been on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB) since 2013, is currently leading PDA’s Post Approval Change Task Force, and PDA’s QRM Interest Group. She led PDA’s Task Force on Drug Shortages and also provided leadership for several PDA Technical Reports.
Emma holds an MS in Pharmaceutical Sciences from University of Connecticut, an MS in Medicinal & Pharmaceutical Chemistry, and a BS in Pharmacy, both from University of Indore, India.