Dawn Wofford has over 18 years as a Quality and Regulatory leader with a mission to facilitate biotech companies’ navigation of the global landscape by delivering compliance and regulatory solutions from product development to marketing and post-marketing activities. Dawn is Wheeler’s Vice President of Quality and Regulatory Affairs with overall responsibilities for establishing and monitoring quality and regulatory programs for the development, manufacture, and distribution of medical products for Wheeler sites. Across the span of her career, she has built quality systems for regulated industries in HTC/Ps, Medical Device and Pharmaceutical companies. Her therapeutic area of expertise includes gene therapy, cellular therapy, regenerative medicine, ophthalmology, oncology, hematology, maternal health, respiratory and COVID indications. Dawn has an extensive reputation of leading successful preapproval inspections, surveillance inspections and delivering multi-country regulatory submissions. Dawn has provided leadership at Cytovance Biologics, AMAG Pharmaceuticals Cord Blood Registry (CBR) and the Hawaii Lions Eye Bank and Makana Foundation. She has a demonstrated history of implementing innovative solutions and by communicating the quality and regulatory landscape by participating in external industry partnerships, developing policy with regulatory agencies, and participate in industry memberships, committees and speaking opportunities. Dawn is a certified Quality Auditor and is a certified Manager of Quality/Operational Excellence both granted by ASQ.