Award Winner (Service Appreciation Award) 2023: Amelia (Amy) Mutere

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About Amelia (Amy) Mutere

Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.
She started out in Nairobi, Kenya in solid oral dosage QA ops, then moved to small molecule API, excipients and diagnostic reagents in a Head of Quality Role for 15 years at SAFC_Millipore Merck. From there, she moved to biologics, ADC and various roles in global QA & Compliance roles:  Supplier Quality, Auditing, External Relations, and Globa Inspection Management Roche/Genentech for 15 years. At Genentech, she was based in both South San Francisco, USA and Basel Switzerland. More recently, Amy worked at Juno later Celgene, BMS in Global Supply Chain Quality managing external CDMOs manufacturing and testing vectors for commercial and clinical CAR-T programs. Continuing in gene therapy, Amy worked as VP of QA and QC at Solid Biosciences. Amy’s most recent experience is in Quality and Compliance at Exelixis.
Amelia (Amy) Mutere