Full Name for Training Certificates: Sheri G Langerman

Job Title: Senior Director Quality Operatioins

Company/Organization: GRAIL, Inc.

Areas of Interest: IVD

Years in Industry: 30+

Bio: I am a seasoned, hands-on senior leader and proven change agent in the medical device industry. I lead GRAIL's Quality Operations team as we navigate through the new Regulatory space for multi-cancer early detection ("MCED") blood screening in vitro diagnostic devices. I am a “bridge-builder” able to resolve difficult, complex issues through creative, compliant problem solving, effective negotiation and the ability to influence in a matrix environment. Having earned seven ASQ Certifications (including Quality Engineer, Six Sigma Green Belt, Biomedical Auditor, and Manager of Quality/Operational Excellence) as well as an MBA and a master’s degree in Regulatory Affairs, I have the technical know-how which enables me to lead significant process improvement projects from concept to completion (CAPA, Validation, Internal Audit, Change Management, Management Review, Quality Planning, and global quality system standardization). I am proud to lead a talented team of Quality professionals and honored to work with many brilliant and dedicated colleagues across our organization.