With over 30 years experience within the pharma/biologics field with advancing roles in Quality, Gail has provided quality leadership and guidance in the start-up of several large-scale facilities both domestically and internationally. She has been pivotal in the licensing of first multi-valent vaccine (HibTiter®) and for successful licensing for world’s first Mab biosimilar in South Korea, EU and several Eastern European and South American countries (Remsima®). She has extensive experience with quality systems, auditing, CROs, CMOs, fill/finish operations, supply chain, computer systems, validation,
regulatory submissions and inspections, pharmacovigilance, and licensed and developmental (phase I-IV) products.
Ward is a graduate of School of Computer Technology with a degree in Computer Programming and holds an AS in Education from Campbell University. She is a CQA and CQIA through ASQ and holds memberships to ACRP, RAPS, ASQ, and ASCM.