Violet M. Carvalho has served as the Head of Quality Assurance at Calidi Biotherapeutics since August 2023. She is an accomplished Quality professional with greater than 25 years’ experience gained working in the US and Canada in the pharmaceutical/biotechnology industry.
Violet has held leadership roles in both Quality Assurance and Quality Control. She was the Senior Director/Director, Quality for Ligand/Pfenex Inc., led the company through process validation, and gained FDA approval for the osteoporosis drug. As Director, Quality Assurance at PaxVax Inc. and in collaboration with key stakeholders drove the cholera vaccine program from phase 1 through commercial launch. She successfully led the site through their first FDA Pre-approval inspection for the cholera vaccine.
Violet served as Director, Quality Systems at Arena Pharmaceuticals. She set up an independent Quality Control Laboratory and established QC teams supporting both development and commercial programs. She provided oversight at corporate and contract sites in the US and Europe and earned FDA approval for the obesity drug. She established the Quality Control laboratory and held positions of increasing responsibility as Head of Quality Control at La Jolla Pharmaceuticals and Apotex Fermentation Inc.
Violet was the QA/QC lead in FDA pre-approval inspections, FDA audits, customer audits, due diligence audits and wrote/reviewed CMC sections for DMF, INDs, NDAs, BLAs.
Violet holds a B.Sc. Chemistry, a B.Ed., University of Bombay and an M.S. Oral Biology, University of Manitoba.
