Herb Anthony

About Herb Anthony

Experienced and proven Quality Assurance, Compliance and Training Leader with over 25 years of demonstrated history working in the pharmaceutical/biotechnology industry. Skilled in Verification and Validation(V&V), analytical laboratory functions and test requirements, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practice (GLP), Medical Devices, Vaccines, Quality Systems and Change Control. Strong operations professional with vast experience in Regulated Inspections, Outcomes, CAPA/Root Cause Analysis. This background fosters building strong teams. My strong presentation and facilitation skills provide depth of my communication skills. Strong understanding of Global relationships and managing Global Quality functions. In addition, I have presented to global audiences around the world on various Quality, Compliance, and Training topics and published articles on various Quality topics.

Experience

1. Senior Director, Quality Assurance

   Kolon Tissuegene, Inc

   Apr 2023 — Present · Rockville, MD, US

Education

• University of Illinois Chicago

  Bachelor's of Science, Chemistry

  1985 — 1989

Skills

• Validation
• Biochemistry
• Infectious Diseases
• Clinical Development
• Vaccines
• Gmp
• Immunology
• Drug Development
• Gcp
• Biopharmaceuticals
• Change Control
• Regulatory Submissions
• Clinical Trials
• Biotechnology
• Computer System Validation
• Pharmaceutical Industry
• Sop
• Fda
• Good Laboratory Practice (Glp)
• V&V
• Molecular Biology
• Glp
• Oncology
• Protocol
• Medical Devices
• Clinical Research
• Regulatory Affairs