Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials. Serve as a subject matter expert and day-to-day leader for a team of Quality Operations Associates by providing technical guidance, coaching, training, work prioritization, and performance support while fostering a culture of quality, collaboration, and continuous improvement.