QA EXPERTISE WITH DEVELOPMENT, INITIATION AND MANAGEMENT OF GLP, GMP, & GCP SYSTEMS. WORKING WITH CLIENT PRODUCTS IN CROSS FUNCTIONAL CMC TEAMS TO MANAGE NON-HUMAN CLINICAL TRIALS, DISPOSITION OF CTM AND COMMERCIAL PRODUCT, GCP MANAGEMENT OF CLINICAL TRIALS ENSURING ADHERENCE TO INTERNATIONAL GXP REQUIREMENTS.
Lisa Reed has twenty-five plus years of experience ensuring GxP compliance within the biologics, gene therapy and pharmaceutical industries with advanced subject matter expertise within the Quality Assurance function. As a highly focused Global Quality professional, she is committed to working with development teams to create and maintain the highest possible quality standards.
Lisa brings considerable technical expertise in development, management and disposition for gene therapy, biologics and small molecules products as well as significant experience ensuring GCP compliance consistent with global regulations and industry expectations. She is the owner and President of L. Reed Global QA, Inc., a consultant company launched at the beginning of 2014. She is fully engaged in the biopharmaceutical life science segment, working with clients to assist in development of phase appropriate programs to meet and exceed industry cGxP requirements by staging product for QP release, regulatory audit support, vendor qualification and management of drug product programs. Previously, Lisa worked globally managing product within CMO operations and as QA Site Director of active manufacturing facilities. Work experience encompasses global early clinical phase development, clinical trial supplies in the clinical setting through commercial approval and serialization. Specific work experience can be viewed on the attached resume.