Amelia Mutere
Technical Quality Professional w expertise in CMC and Clinical, inspections/audits in cell, gene, biologics, small molecule, & ADC. Expertise in FDA, EMA, MNPA, ANVISA, Cofepris and other health authorities.
- Role
- Vice President Quality Assurance - Product Quality at Savara Inc.
- Location
- Antioch, CA, US
- LinkedIn followers
- 500 followers
About Amelia Mutere
I am a quality professional with over 30 years of experience in site and global quality roles. I have a high expertise on technical teams going from early phase IND filing to commercial approval. I have extensive experience in FDA, EMA, Cofepris, ANVISA, China, Russia regulations and compliance. Technologies I have worked are cell therapy, CAR-T, lentiviral vectors, gene therapy rAAV vectors, ATMPs, excipients, plasmids, biologics drug product and drug substance, small molecule API, DP, oligonucleotides, and antibody drug conjugates. I specialize in CMC, compliance, external relations, quality systems, and inspection readiness and PLI/PAIprep. I also work in the external influencing interactions and mutual reliance. I can audit non-GLP, GLP, GCP, and GMP facilities.
Experience
Vice President Quality Assurance - Product Quality
Jun 2025 — Present
Education
University of Nairobi
M.S, Environmental Chemistry
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