Joy Langley
Exemplar Compliance, LLC.
Operations Director
Joy Langley is Director of Operations for Exemplar Compliance, LLC. She has over 20 years of experience spanning academics, electronics, medical device, biologics, pharmaceuticals, and combination products, and has regulatory expertise in a variety of global markets. Throughout her career, Langley has functioned in the capacities of research, process engineering, quality engineering, lean manufacturing, and quality assurance for small, mid-size, and Fortune 500 companies. Her product experience includes Class I, II, III medical devices, combination drug/device/biologics, drug/device, (IVD kits, infectious disease blood testing, balloons, stents, drug-eluting stents, catheters, surgical gloves, OTC home-testing kits), industry software, and supplements. For nearly 10 years, Langley has provided expert consulting in regulatory inspection remediation, quality system integration and development, validation, CAPA, audits, pre-approval inspection readiness, and industry software development and implementation. She has helped organizations successfully pass unannounced FDA inspections, develop quality systems from scratch, remediate warning letters and consent decrees, prepare for new product launches, and implement lean operations systems. Langley holds a bachelor’s degree in Chemistry, an MBA with a concentration in business development and strategy, and is an ASQ-certified quality manager (CMQ/OE – certified manager of quality and organizational excellence). She was inducted into Sigma Xi: The Scientific Research Honor Society for her discovery of novel inorganic compounds used for anti-cancer applications. Her scientific research has been published in Inorganica Chimica Acta, and her business research is featured in the book “The Well-Timed Strategy.”
