Alice Redmond, PhD is Vice President, Europe Operations at Commissioning Agents, Inc. She has more than 28 years’ extensive experience in lifecycle management of pharma facilities inclusive of regulatory compliance, facility & process design, technology transfer, commissioning, qualification, and validation. Previously Ms. Redmond worked for 9 years for Sandoz/Novartis in Basel, Kundl and Ireland in the areas of quality, validation and technical operations. Following Novartis, Alice led the Global Regulatory, Commissioning and Qualification Group for a Global Engineering Company for 13 years.
Alice has significant large global project experience of green field facilities including fill finish, biotech, gene therapy, medical devices, small and large molecule API and OSD from design through to operational readiness. She has presented projects internationally to numerous regulatory agencies and has facilitated many clients to PAI readiness or remediation. Alice regularly presents for ISPE, PDA and RAPS and was recently awarded a lifetime achievement award for PDA Europe. She is a former winner of the ISPE Robert F. Sherwood Article of the Year Award. She was a committee member on the Biotech and Disposables CoPs and Lead on the Knowledge Assets Committee. Alice currently serves on the ISPE C&Q CoP Steering Committee and is a former co-chair of this committee. She is on the ISPE Commissioning and Qualification Baseline® Guide Revision Team and serves as a training instructor in QRM for ISPE and collaborative ISPE and NIBRT training. Alice participated in the inaugural Women in Pharma forum at ISPE Annual Meeting 2016. Alice holds a PhD in Cell Culture from Dublin City University, an MBS in Project Management from University of Limerick and a Degree in Biotechnology from Dublin City University.