Kelly M. Miller, MSc.

Kelly M. Miller, MSc.

Kelly M. Miller, MSc.

Director

Kelly has over 23 years of experience within the regulated industry to help US and international clients prepare and manage FDA GMP quality systems to meet quality improvement objectives. She brings a diverse range of quality system expertise in pharmaceutical commercial and medical device manufacturing, Quality Management Systems development, improvement and remediation, as well as the management of regulatory affairs. She has developed quality management systems to support product design and development, manufacturing, packaging/labeling, and provided quality assurance oversight management for biopharmaceutical industry clients.

Work Experience

Previously, Kelly directed a research and development team as well as a quality team and developed and implemented the quality control systems and procedures for the research, manufacturing, and packaging of topical pharmaceutical products both OTC and Rx, and topical medical devices with the Quality System Regulation. While with Vectech Pharmaceutical Consultants, Kelly provided consulting services to the regulated industry and supported client warning letter remediation efforts, offered strategic advice for business improvement objectives and worked closely with client’s QA departments in a variety of roles to improve their quality systems. 

Education

Kelly holds a MSc in Chemistry from Oakland University (Rochester, MI) and a BSc in Chemistry from University of South Florida (Tampa, FL). In addition, she has obtained the ASQ Pharmaceutical GMP Professional Certification (ASQ–CPGP) in 2016. She has presented at several pharmaceutical association meetings and peer reviewed Laboratory Validation, A Practitioner’s Guide, published 2003 by PDA/DHI.

We are always available for a conversation.

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