David Gutierrez
About David Gutierrez
David Gutierrez is a Sr. Manager of Quality Assurance with extensive experience in supplier management and quality assurance processes. He has held various positions in the pharmaceutical industry, including roles at COR Therapeutics, Gilead Sciences, and Sangamo Therapeutics, and holds certifications as an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional.
Work at Sangamo Therapeutics
David Gutierrez serves as the Senior Manager of Quality Assurance at Sangamo Therapeutics, Inc. since 2019. In this role, he focuses on ensuring compliance with quality standards and regulatory requirements. His responsibilities include the review of drug product labeling and the Chemistry, Manufacturing, and Controls (CMC) section of regulatory submissions. Gutierrez's expertise in quality assurance contributes to the overall integrity of the pharmaceutical products developed by the company.
Previous Experience in Quality Assurance
Prior to his current position, David Gutierrez held several roles in quality assurance across various organizations. He worked at COR Therapeutics/Millennium Pharmaceuticals as a Quality Assurance Manager from 1998 to 2004. He then joined Gilead Sciences as a Quality Assurance Specialist III from 2004 to 2010. Additionally, he served as a Quality Systems Associate Manager at Dynavax Technologies from 2018 to 2019, and as a Senior Regulatory Compliance Associate at Impax Laboratories from 2012 to 2017. His diverse experience spans multiple aspects of quality assurance in the pharmaceutical industry.
Education and Expertise
David Gutierrez earned a Bachelor of Science degree in Biochemistry from the University of California, Davis. His educational background provides a strong foundation for his expertise in quality assurance, supplier management, and compliance auditing. He holds certifications as an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional, which further validate his knowledge and skills in the field.
Specializations in Quality Assurance
Gutierrez specializes in various aspects of quality assurance, including internal and external compliance auditing for Contract Manufacturing Organizations (CMOs), Contract Packaging Organizations (CPOs), and Active Pharmaceutical Ingredient (API) manufacturers. He is experienced in the review of batch records, in-process results, and Quality Control (QC) results. His skills also encompass the investigation of deviations, non-conformances, and product complaints, as well as the disposition of drug products and raw materials.
Achievements in Pharmaceutical Development
David Gutierrez has extensive experience in the clinical development and commercialization of pharmaceutical drug products. His work includes involvement in various dosage forms such as tablets, capsules, and injectables. He is skilled in reviewing qualification and validation protocols and reports, which are critical components in ensuring product quality and compliance with regulatory standards.