Myles Kramer
About Myles Kramer
Myles Kramer serves as the Vice President of Quality Assurance at Verrica Pharmaceuticals, where he has worked since 2022. With extensive experience in quality management across various pharmaceutical companies, he has held senior roles at organizations such as Amneal Pharmaceuticals and Roche.
Work at Verrica Pharmaceuticals
Myles Kramer serves as the Vice President of Quality Assurance at Verrica Pharmaceuticals, a role he has held since 2022. In this position, he is responsible for overseeing quality assurance processes and ensuring compliance with regulatory standards. Prior to this role, he was the Executive Director of Quality Assurance at the same company from 2021, contributing to the establishment of quality management systems and practices. His work at Verrica Pharmaceuticals is based in West Chester, Pennsylvania.
Previous Experience in Quality Assurance
Myles Kramer has extensive experience in quality assurance across various pharmaceutical companies. He worked at Amneal Pharmaceuticals as Senior Director, Head of Quality for Third Party Manufacturing from 2017 to 2020. Prior to that, he held senior positions at Roche, Molecular Systems, where he served as Senior Director of Quality Management from 2004 to 2011 and as Director of Quality Assurance from 2001 to 2004. His experience also includes roles at Impax Laboratories, NorthPoint Consulting, LLC, and CorePharma LLC.
Education and Expertise
Myles Kramer has a strong educational background in biology and quality engineering. He studied at Seton Hall University, where he completed graduate studies in Biology and Advanced Biology. He also holds a Master of Science in Quality Engineering from Lehigh University. Additionally, he earned a Bachelor of Science in Biology from Albright College. His education complements his expertise in quality management systems and regulatory compliance in the pharmaceutical industry.
Quality Management Initiatives
Throughout his career, Myles Kramer has implemented significant quality management initiatives. He oversaw quality management for 35-40 third-party sites handling over 45 different products. He established and implemented comprehensive Commercial Quality Systems, including an electronic Quality Management System (QMS). Additionally, he has managed quality oversight for the development and commercialization of novel drug and device products, demonstrating his expertise in both pharmaceutical and device quality assurance.
Specialized Knowledge in Diagnostics and Combination Products
Myles Kramer possesses specialized knowledge in PCR-based Molecular Diagnostics and Combination Pharma and Device products. His experience includes implementing a multi-site Device Design Control system, which highlights his capability in managing complex quality assurance processes. This expertise is essential for ensuring the safety and efficacy of innovative healthcare products.