Monica Abakar

Senior research compliance and quality leader with more than 14 years of experience overseeing Human Research Protection Programs (HRPP) and IRB operations in highly regulated, multi-site healthcare and academic environments. Expert in federal human subjects regulations (45 CFR 46, FDA, OHRP, HIPAA), research ethics, audits, and risk-based compliance strategies. Proven ability to develop enterprise-wide policies, lead regulatory audits and corrective actions, and deliver impactful education and training programs. Trusted partner to researchers, regulators, and senior leadership, recognized for advancing compliant, high-quality research operations.
 

Quality Assurance Program Director
Al Jadid Table Water ▪ Kano ▪ Nigeria
08/2019 – 2025

• Led an organization-wide Quality Management System (QMS) overseeing regulatory compliance, operational risk, and continuous improvement across production, safety, and distribution functions.
  Directed internal audit programs, identified systemic compliance gaps, and led corrective and preventive action (CAPA) initiatives to mitigate operational and regulatory risk.
• Served as primary liaison to federal regulatory authorities, coordinating inspections, responding to findings, and supporting regulatory reporting and documentation.
• Partnered with senior leadership to translate regulatory requirements into operational policies, procedures, and performance standards.
• Strengthened accountability and governance by providing guidance to supervisors on budget and personnel decisions, performance issues, and corrective actions.

Program Coordinator | Human Research Protection Program
University of Southern California ▪ Los Angeles ▪ United States 
06/2010 – 04/2019

• Defined and implemented policy strategy for the Human Research Protection Program (HRPP) at USC, a large, multi-site academic institution.
• Developed, and maintained IRB and HRPP policies governing human subjects research in compliance with 45 CFR 46, FDA regulations, OHRP guidance, HIPAA, California Code, and AAHRPP accreditation standards at an institution with multiple FWAs and multiple-IRBs.
• Oversaw Institutional Review Board (IRB) submission review workflows and supervised IRB reviewers, ensuring consistency, regulatory adherence, and quality decision-making.
• Participated in performance evaluations, coaching, and succession planning for IRB graduate student staff, providing ongoing feedback, identifying development needs, and preparing high-potential individuals for increased responsibility within IRB operations.
• Managed HRPP budget; tracking expenditures, forecasting needs, and preparing monthly financial reports for the Executive Director.
• Supported post-approval monitoring and quality improvement activities, including review of protocol deviations, reportable events, and compliance trends.
• Collaborated cross-functionally with legal, compliance, privacy, and research leadership to address complex issues and implement corrective actions.
• Produced and maintained HRPP communications, web content, and regulatory guidance accessed by thousands of active investigators, supporting consistent application of compliance standards across departments.

Master of Regulatory Science (MRSc) ▪ 2017
University of Southern California 

Bachelor of Arts in Sociology 
University of California Los Angeles ▪ 2008