Mark Roache | VP, Cell and Gene Therapies
Quality Executive Partners, Inc.

Mark Roache , VP of Cell and Gene Therapies for Quality Executive Partners, Inc., is a senior quality executive and consultant specializing in advanced therapies including cell & gene therapy, drug conjugates, and other ATMP modalities. With a career spanning more than three decades, he has led global quality strategy, major systems implementations, and GxP operations across pharma, biotech and CDMO manufacturing environments. Mark’s core strength lies in translating regulatory expectations into actionable plans that support approval and product supply without compromising compliance or data integrity. He does this by simplifying complex regulatory and technical challenges across Quality, Operations and technical functions by focusing on shared goals and outcomes. Mark believes strongly in the value of quality culture as a way of achieving and maintaining this alignment and focus, putting the patient’s interests first and resulting in a culture where quality is owned and celebrated. Mark 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.