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 (Use the "Apply for this Job" box below)..

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.

The Manager independently directs and supervises the day-to-day management of critical regulatory requirements and quality assurance activities for clinical research within CCR. The Manager has primary responsibility for overseeing the Regulatory Affairs Supervisor, who manages staff responsible for submitting protocols to clinical research committees (e.g., Institutional Review Board [IRB]), and the Quality Assurance and Improvement Supervisor, who is responsible for monitoring, auditing, and continuous improvement of clinical research operations.

The Manager is responsible for directing, administering, and achieving operational goals and objectives for the implementation and oversight of new operational strategies and unit goals within the regulatory and quality assurance arenas. This includes staffing, work assignment, implementing the performance management program, leading staff learning and development, leave management, and all other HR-related functions across both units. The Manager builds and maintains a culture of excellence, safety, and compliance with the goal of achieving an audit-ready operation at all times.

This position is responsible for establishing and maintaining strong relationships with investigators, clinicians, coordinators, administrators, patients, sponsors, site monitors, and institutional compliance bodies. Provides high-level analytical support for strategic initiatives for the regulatory and quality assurance operations and implementations of CCR's clinical trial portfolio. Work is primarily on-site across clinical and administrative locations. Remote work will only be approved with authorization from the Assistant Director.

Qualifications

Required:

* Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters

* Demonstrated experience in supervising staff in a research environment, including managing supervisors and multi-level teams

* Demonstrated strong management, leadership, and supervisory skills across a diverse population

* Deep content expertise in clinical research regulatory affairs and quality assurance operations

* Proven track record of excellent…