Eric English, MS, CBA, RAC

Eric English serves as a Senior RA/QA Advisor for Pearl Pathways. Eric has over 18 years of experience in quality, regulatory, and auditing roles in the life sciences industry, including over a decade of experience in quality and regulatory consulting. 

Prior to joining Pearl Pathways, Eric’s consulting work included developing, implementing, and managing GMP quality systems for multiple pharmaceutical startups, leading the external audit program for one of the world’s largest CROs, and medical device regulatory strategy and filings.  Before becoming a consultant, Eric helped to develop, implement, and manage the quality and compliance infrastructure at a biotech CDMO/CTO performing early phase cell culture and protein purification, GMP cell banking, and tissue-based therapy development and testing.

Eric’s expertise includes an extensive background in quality and compliance auditing against 21 CFR Part §210/211, ICH Q7a, 21 CFR Part §820, ISO 13485, 21 CFR Part §1271, ISO 15189, CAP, CLIA, GCP, and GCLP regulations, medical device regulatory experience across multiple orthopedic implant classes and IVDs, experience managing compliance for early phase pharmaceutical startups developing early phase oncology and diabetes therapies. 

Eric is a BSI Accredited ISO 13485:2016 Lead Auditor and holds a Regulatory Affair Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS). He is also an ASQ Certified Quality Auditor (CQA) and Certified Biomedical Auditor (CBA). Eric has a BS in Chemistry from Haverford College and an MS in Biotechnology from Johns Hopkins University.