2026 June Austin Section ASQ General Meeting

Topic: R U Ready for RUs?

Speaker: Melanie Berry, CMQ/QE, CQIA, CTBS

Bio: 
Melanie Berry is an industry-leading quality assurance and operations consultant with nearly two decades of experience navigating complex regulatory frameworks across drugs, tissues, and biologics. As the 2026 Vice Chair and former Chair of ASQ Austin, Melanie is deeply committed to fostering a strong quality culture through education and strategic CMO collaboration. She has steered regulatory compliance, infrastructure design, and electronic Quality Management Systems (eQMS) across the federally regulated biopharma, tissue, and biologics sectors, with a track record of transforming startup operations and scaling enterprise systems. Melanie has served as Director of Quality at Direct Biologics and as a strategic consultant managing high-value clinical and commercial accounts for global organizations such as Johnson & Johnson. Her subject matter expertise spans cGXP compliance, international cold chain logistics, and cross-functional technical product ownership of life-science software platforms including Montrium and MasterControl. A recognized industry speaker, she contributes through executive board work and national committee leadership within ASQ and the Association for Advancing Tissue and Biologics (AATB). She holds multiple professional certifications and a degree from the University of Texas, specializing in risk mitigation, continuous improvement, and regulatory compliance.

Speaker Agenda: This session breaks down the recent updates to ISO-accredited ASQ certifications and outlines the streamlined Recertification Unit (RU) accrual process. Built as an interactive resource for both ASQ Quality Members and Member Leaders, it is designed to spark thought, drive discussion, and encourage professional innovation across sections. Every attendee will receive an editable copy of the presentation deck, formatted for immediate use in peer-to-peer discussions or as a turnkey template for future Member Leader-led presentations