Alice is a Senior consultant with >28 years extensive experience in Lifecycle Management of Pharma facilities inclusive of Regulatory Compliance, Process Design, Technology Transfer, commissioning, qualification, and validation. Alice Joined CAI 4 years ago and holds the position of VP for CAI Europe and Biopharma and Medical Devices Business Area Lead for Commissioning Agents International. Previously Alice worked for 9 years for Sandoz/Novartis in Basel.Kundl and Ireland in the areas of Quality, Validation and Technical Operations. Following Novartis Alice lead the Global Regulatory, Commissioning and Qualification Group for PM Group for 13 years.
Alice has significant large project experience of global green field facilities including Fill Finish, Biotech, Gene therapy, Medical Devices, Small and large molecule API and OSD facilities, many of these projects included multiple capital projects in excess of $300million. She has presented projects globally to numerous regulatory agencies and has facilitated many clients to PAI readiness or remediation, she regularly presents for ISPE, PDA and RAPs and was recently awarded a lifetime achievement award for PDA Europe. Alice is a former winner of the Robert Sherwood ISPE award for article of the year and she is currently on the ISPE C&Q COP steering committee, on the Committee re-writing the ISPE C&Q guide and global trainer in QRM for ISPE.