Mark Roache

Mark has spent his entire career working in GXP with more than 30 years of industry experience, from development, through technical operations and quality management. He held the position of Chief Quality Officer for AveXis (now Novartis Gene Therapies) at the time of Zolgensma launch. He was previously Senior VP of Quality for KBI (a CDMO with cell-therapy capabilities) and has held other senior Quality roles at Novartis, Merck and Bayer. He also has extensive experience in vaccines, recombinants and aseptic processes. 

Mark sees the role of Quality as being the navigators in technical risk management and as champions for the interests of the patient. Using that approach, he has successfully brought many different drugs to market, and his deep experience in biotech has allowed him to help a wide variety of companies with everything from Data Integrity, Strategic Risk Management, all the way to Emergency Compliance Remediation. 

He firmly believes that it takes a whole organization to develop and deliver novel treatments to patients and is passionate about working effectively together towards that goal.