Highly experienced scientist with over 20 years of expertise in quality assurance, product performance, and analytical chemistry in the pharmaceutical and medical device industries. Demonstrated success in ensuring compliance with ISO standards, ICH, USP, and cGMP regulations while leading complex method development and validation projects. Proven ability to effectively manage QA Lab operations and foster regulatory and cross-functional collaboration to ensure safety and quality throughout the product lifecycle. Skilled in utilizing quality tools, design controls, and regulatory frameworks to optimize product performance and maintain compliance.