Violet M. Carvalho

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

Experience

1. Head of Quality, Vice President, Quality Assurance

   Calidi Biotherapeutics

   Aug 2025 — Present · 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

• CRO
• Strategic Leadership
• Cross-Functional Team Leadership
• Biotechnology
• Pharmaceutical Industry
• Sop
• Fda
• Microbiology
• 21 Cfr Part 11
• Vaccines
• Glp
• Quality Control
• Gmp
• Change Control
• Regulatory Affairs
• Lifesciences
• Quality Agreements
• Problem Solving
• Validation
• Risk Management
• Lims
• Quality System
• V&V
• Capa
• Chromatography
• Product Quality
• Pharmaceuticals
• Regulatory Requirements
• Ind
• Gxp
• Quality Auditing
• Aseptic Processing
• Chemistry
• Laboratory
• Drug Development
• Biopharmaceuticals
• Online Communications
• Analytical Chemistry
• Technology Transfer
• Clinical Trials