Jacques Mourrain

Biography

Jacques Mourrain began his biopharma career some 20 years ago developing control system applications for pharmaceutical freeze-drying. After a brief stint as a solo validation consultant, he joined Fluor Daniel, as the director of validation, where he was responsible for multiple projects in biopharmaceutical facility validation, including the qualification of clean utilities, process equipment, process automation, and enterprise information systems. Right after Y2K, he joined Genentech to lead the software quality assurance group within medical affairs. In 2002, Dr. Mourrain founded the GxP Computer System Compliance function at Genentech, a group responsible for IT compliance across the regulated landscape. In this role he led multiple initiatives, including 21CFR Part 11 remediation and Oliver Wight Class A process optimization. Jacques has extensive knowledge of software development best practices, validation principles, and quality systems used in an FDA/EMA regulated environment. He is an established thought leader in the area of computer systems compliance, validation, and auditing. He has presented at diverse venues such as DIA, ISPE and PDA conferences and has published on a range of topics from compliance auditing, change control, cost-of-quality, and computer systems validation.

Research Interest

life science