Regulatory Affairs & Quality Assurance Manager

University of California, Irvine•Orange, CA

16h•Onsite

About The Position

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.

Requirements

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 leadership required for fostering effective collaboration between executive leadership and research operations leadership
Demonstrated ability to lead strategic initiatives across regulatory and quality functions
Effective oral and written communication skills with technical writing skills sufficient to compose a variety of scientific documents, reports, and justifications which are clear, concise, logical, and grammatically correct
Working knowledge of clinical protocol design, content, and categories for inclusion in a final document
Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy
Ability to establish and maintain cooperative working relationships with colleagues, faculty, and staff
Excellent interpersonal, organizational, and time management skills
Ability to work both independently and as part of a team
Ability to take initiative and demonstrate strong commitment to duties
Ability to act independently with demonstrated problem-solving skills, multi-task, and to follow through on assignments with minimal direction
Ability to accept equivocal circumstances and take action where answers to a problem are not readily apparent
Ability to analyze complex problems involving long-range planning including sources for information and data, and summarizing information into a logical format for presentation
Organizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrative
Skill in performing a variety of duties, often changing from one task to another with frequent interruptions
Skill in composing letters, preparing documents, and facilitating the production of materials
Experience with clinical research and data collection methods
Ability to work within a deadline-driven structure
Demonstrated experience in maintaining flexibility and adaptability while leading and implementing institutional change
Foster and promote a positive attitude and professional appearance
Expertise with Microsoft Office (Word, Excel, Outlook, PowerPoint)
Experience working in OnCore Clinical Trials Management System (CTMS) or equivalent
Experience working in a multidisciplinary matrixed work environment
Thorough understanding of FDA regulations, GCP, ICH guidelines, and HIPAA requirements pertinent to research
Knowledge and experience with quality assurance methods, CAPA development, and audit management
Experience working with IRB, FDA, and other regulatory bodies
Bachelor's degree in related area and / or equivalent experience / training
Clinical Trial Professional certification from a professional society within one year in position.
Minimum 5-7 years of related work experience with BA/BS or equivalent experience in regulatory oversight and/or quality assurance in an academic and/or clinical research environment
Must be able to provide proof of work authorization

Nice To Haves

Knowledge of research billing and budget management
Familiarity with FDA inspection process
Advanced degree preferred.

Responsibilities

Oversee all clinical research regulatory and quality assurance operational matters.
Directly oversee the Regulatory Affairs Supervisor and the Quality Assurance and Improvement Supervisor and their respective teams.
Accountable for unit-level operational effectiveness across regulatory compliance, quality assurance, training, and process improvement functions.
Lead workforce planning, operational strategy development, and continuous quality improvement initiatives.
Direct and supervise the day-to-day management of critical regulatory requirements and quality assurance activities for clinical research within CCR.
Oversee the Regulatory Affairs Supervisor who manages staff responsible for submitting protocols to clinical research committees (e.g., Institutional Review Board [IRB]).
Oversee the Quality Assurance and Improvement Supervisor who is responsible for monitoring, auditing, and continuous improvement of clinical research operations.
Direct, administer, and achieve operational goals and objectives for the implementation and oversight of new operational strategies and unit goals within the regulatory and quality assurance arenas.
Manage staffing, work assignment, implement the performance management program, lead staff learning and development, and manage leave for both units.
Build and maintain a culture of excellence, safety, and compliance with the goal of achieving an audit-ready operation at all times.
Establish and maintain strong relationships with investigators, clinicians, coordinators, administrators, patients, sponsors, site monitors, and institutional compliance bodies.
Provide high-level analytical support for strategic initiatives for the regulatory and quality assurance operations and implementations of CCR's clinical trial portfolio.