Amelia (Amy) L. Mutere, MS Genentech, a member of the Roche Group

Amelia (Amy) has been working at Genentech/Roche for the past 12 years in various Quality Functions. Amy is currently leading the Global Quality Inspection Management group supporting Roche Internal Sites, CMOs, and Partner Health Authority Inspections. Roche hosts health authorities from USA, EMA, China, Russia, Mexico, Brazil and other countries. Amy has been in this role for the past 4 years, she was originally located in Basel Switzerland to set up the European side of the Global Quality Inspection Management Group for 3 years. Prior to this role, Amy worked in the GMP Audit Operations in South San Francisco responsible for the GMP audit responses and GMP auditing. Prior to GMP Auditing, Amy worked in Global Supplier Quality in Supplier Collaborations. Here she worked in Supplier Risk Management, auditing for early phase molecules at CMOs, and Supplier Collaboration where she worked on improvement projects with suppliers such as stoppers, glass vials/syringes, cell culture, purification and excipients direct materials. Prior to Genentech, Amy worked as a Quality Site Head in Sigma Cleveland facility (then called Research Organics). In 15 years at this site, Amy worked in Analytical Services, QC, QS, and as a Quality Site Head.