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Gayle Heffernan is an accomplished executive with extensive experience in quality operations and assurance within the pharmaceutical industry. Currently serving as the Executive Director of Quality Operations at PTC Therapeutics, Inc., Gayle leads a team of 13 professionals, managing quality for clinical and commercial products with a focus on GMP regulations across the Americas and Europe. Previously, Gayle held multiple leadership roles at Daiichi Sankyo, Inc., including Senior Director of Quality Assurance, where responsibilities encompassed global GMP management and vendor oversight. With a robust background in computerized system validation and extensive consulting experience for various pharmaceutical companies, Gayle is well-versed in quality processes and compliance. Gayle holds a BS in Pharmacy from Rutgers University.