Regulatory Affairs & Quality Assurance Manager

Overview

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu. The UCI Center for Clinical Research (CCR) is driven to improve health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic.

Responsibilities

Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Manager of Regulatory Affairs and Quality Assurance is responsible for all clinical research regulatory and quality assurance operational matters in fulfilling the mission of CCR under the University of California, Irvine - School of Medicine and the overall UC Irvine Health enterprise. Serving as an administrative and operational leader, the Manager directly oversees the Regulatory Affairs Supervisor and the Quality Assurance and Improvement Supervisor and their respective teams, and is accountable for unit-level operational effectiveness across regulatory compliance, quality assurance, training, and process improvement functions. The Manager leads workforce planning, operational strategy development, and continuous quality improvement initiatives that support CCR's mission, regulatory compliance standards, and financial sustainability....