Violet M. Carvalho
Head of Quality, Vice President, Quality Assurance @Calidi Biotherapeutics
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WORK HISTORY
Head of Quality, Vice President, Quality Assurance @Calidi Biotherapeutics
San Diego, CA, US
Head of Quality Assurance providing strategy and oversight of Quality and assuring overall GLP, GCP, GMP, GxP compliance with regulatory requirements and guidelines.
EDUCATION
University of Manitoba, Canada
MS, Oral Biology
University of Bombay, India
Bachelor of Science (Honors), Chemistry
University of Bombay, India
Bachelor of Education, Science, Math
SKILLS
ABOUT VIOLET M. CARVALHO
QUALITY ASSURANCE EXECUTIVE• Strategic Quality Assurance and Compliance Leader with over 25+ years in the pharmaceutical/ biotech industry providing CGXP compliance oversight to preclinical, clinical supply, and commercial products.• Proven record of successfully guiding biotech companies transition from pre-clinical, phase I to to commercialization. • Demonstrated ability to envision and implement quality systems, quality assurance, and quality control strategies and develop high performing teams. • Fostered collaborative, successful partnerships with contract organizations and partners, that led to timely resolution of deficiencies and successful outcomes.• Led/key participant in successful FDA pre-approval inspections, client, and due diligence audits. • Mentored staff and cross functional team and fostered employee engagement. • Expert troubleshooting skills: determined root cause and implemented effective solutions for risk mitigation. • Detail oriented, with good organizational, project management and transparent communication skills. Core competencies include:• Quality Leadership • Quality Systems •Quality Assurance • Quality Control • Regulatory Compliance • Vendor/Due Diligence Audits • FDA Pre-Approval Inspections• Supplier Qualification • Risk mitigation • Strategic Leadership
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