Dr. Carlos Herrero Sanchez

Senior Associate 

Carlos has over 28 of experience in the Pharmaceutical industry with over 20 years of experience managing Quality Assurance, Quality Control and Compliance within Pharmaceuticals, Biopharmaceuticals, Vaccines, and Chemical API companies.  In his roles as senior management, he has been an integral part of design, construction, qualification, and start-up of a large biotech facility, that included design and implementation of Quality Systems, preparing Regulatory Dossiers, and preparing for and managing the site for inspections by Health Authorities (Swissmedic, FDA, EMA, Health Canada).  Carlos has led site preparation for FDA inspections throughout Europe, Mexico, Canada, and Asia. The scope of his experiences includes production, testing, and packaging of Biotechnology, Vaccines, and solid dose products.  He also has a wealth of experience in the production of  biotech API products. 

 

Carlos key skills and experience include but are not limited to:

 

  • Designing and establishing a global quality assurance program along with the respective quality management systems (Change Control, Deviation, OOS, Audit, Training, CAPA, Data Integrity, CSV, etc.) in Europe, Asia, and Latin America

  • Managing site preparation for inspections in Switzerland, Spain, Italy, India, Mexico, China, and The Netherlands

  • Managing warning letter response preparation, coordinating the remediation actions, and follow up inspections which resulted in reintroduction of the  product to the market

  • Managing manufacturing process upgrade and redesigning the quality managed system for a global chemical API manufacturing company

  • Managing several cross-functional projects (QA, QC, Production, RA, Development, Engineering).

  • Implementing a Quality Risk Management program

  • Designing and implementing global program for development and coaching of quality professionals

  • Executing GMP audits, mock inspections, and due diligence

 

Carlos has worked as the Head of Corporate Quality Function in Centrient Pharmaceuticals, as the Senior Director Quality Management & Compliance, Global Quality Assurance at GSK Vaccine, and Director Corporate QA at Merck KGaA, Darmstadt. Prior to that he worked in positions of increased responsibilities within Laboratory, Production, R&D, Quality Assurance and Regulatory Affairs in Serono Biotech.