Theodore Riley
Dacula
Summary
Highly motivated and results-oriented Compliance Professional with 15+ years of experience in developing, implementing, and maintaining robust compliance programs across diverse industries. Proven ability to identify and mitigate risks, conduct thorough investigations, and ensure adherence to regulatory requirements. Great at optimizing business processes, developing effective training programs, and fostering a positive culture of compliance. Skilled in risk assessment, leadership, communication, collaboration, and talent development.
Strategic-thinking individual experienced in turning low-performing organizations into top revenue producers. Offering engaging and pleasant personality with expertise improving customer relationships.
Overview
15
15
years of professional experience
Work History
Director of University Compliance
Tuskegee University
01.2024 - Current
- Provided leadership and oversight to all university compliance functions
- Oversaw the development and implementation of university-wide education, initiatives, monitoring, training, and outreach related to the campus compliance program, including (but not limited to) the Clery Act, and local, state, and federal ordinances and statutes
- Led Research Compliance, Regulatory, and Research Training & Education efforts
- Responded to all alleged violations of rules, regulations, policies, procedures, and codes of conduct by evaluating and initiating investigative techniques
- Developed, oversaw, and evaluated systems för uniformly handling such violations
- Monitored daily compliance activities and direct all tactical matters
- Assisted in quarterly reporting to the Management Compliance Committee
- Functions as a subject matter expert to teammates for compliance-related information
- Oversaw development, review, advancement of internal compliance policies, procedures, tools, and resources to ensure compliance with applicable obligations, including requirements imposed by with Federal and State healthcare programs
- Ensured that the compliance programs throughout the University were effective and efficient in identifying, preventing, detecting, and correcting noncompliance with applicable laws and regulations
- Served as the designated Ethics Officer and University official responsible for establishing standards and implementing procedures
- Established and maintained relationships with regulatory bodies, reported on compliance performance
- Designed and delivered training programs on research protections, IRB review, and quality management
- Oversaw COI and COC management, ensuring adherence to all accreditation standards
- Managed program records and ensured information security and data protection
- Collaborated with cross-functional teams (Data, Regulatory Affairs, Quality Assurance) on enterprise solutions
- Performed ongoing risk assessments and gap analysis for compliance and training programs
Lead Regulatory Compliance Training Consultant
Ennaid Therapeutics
09.2022 - 01.2024
- Led Research Compliance, Regulatory, and Research Training & Education efforts
- Led training clinical trial processes alignment
- Led GCP training on compliance regulations, and 21 CFR guidance’s and guidelines
- Established and maintained relationships with regulatory bodies, reported on compliance performance
- Designed and delivered training programs on human research protections, IRB review, and quality management
- Oversaw COI and COC management, ensuring adherence to all accreditation standards
- Managed program records and ensured information security and data protection
- Collaborated with cross-functional teams (Data, Regulatory Affairs, Quality Assurance) on enterprise solutions
- Performed ongoing risk assessments and gap analysis for compliance and training programs
Director of Regulatory Practice Operations
Halloran Consulting
11.2021 - 09.2022
- Managed regulatory and compliance training for global consultants, focusing on clinical trial processes and clinical quality assurance
- Led the development of new vendor research compliance and Human Research Protection Program policies
- Partnered with regulatory leads to provide training on managing COI and COC in clinical research
- Assisted with talent acquisition, building a pipeline of top talent, and providing input on job descriptions
Contract Compliance Training Consultant
RegenxBio Inc.
01.2021 - 01.2022
- Designed and facilitated medical affairs compliance and regulatory training programs
- Managed the Research Compliance program, prioritized eliminating research-related COIs
- Oversaw internal audits training procedures for clinical and medical affairs groups
- Collaborated with HR to develop a robust onboarding process with learning and development activities
Sr. Manager, Global Clinical Development Operations – Training
Pharmacyclics Inc.
05.2017 - 01.2021
Contract Clinical Global Project Manager & Training Consultant
BCG
08.2012 - 05.2017
Regulatory Health Project Manager
FDA Center for Tobacco Products
02.2011 - 08.2012
Contract QA/CRA/Compliance Manager
A10 Solutions/Piedmont Health Research Institute
09.2009 - 01.2011
Education
Ph.D. -
Educational Leadership
01.2026
M.S. - Biology
Southern University
01.1996
B.S. - Biology
Tuskegee University
01.1994
Skills
- Research Ethics & Compliance
- Government regulations (FDA, OSHA, ICH, HIPAA)
- Project Management
- Risk Assessment
- Deep understanding of end-to-end compliance risk processes
- Organizational Awareness
- Independently led and managed cross-functional initiatives
- Excellent communication skills
- Budget Management & Personnel Development
- Conflict of Interest (COI) & Conflict of Commitment (COC) Management
Timeline
Director of University Compliance
Tuskegee University
01.2024 - Current
Lead Regulatory Compliance Training Consultant
Ennaid Therapeutics
09.2022 - 01.2024
Director of Regulatory Practice Operations
Halloran Consulting
11.2021 - 09.2022
Contract Compliance Training Consultant
RegenxBio Inc.
01.2021 - 01.2022
Sr. Manager, Global Clinical Development Operations – Training
Pharmacyclics Inc.
05.2017 - 01.2021
Contract Clinical Global Project Manager & Training Consultant
BCG
08.2012 - 05.2017
Regulatory Health Project Manager
FDA Center for Tobacco Products
02.2011 - 08.2012
Contract QA/CRA/Compliance Manager
A10 Solutions/Piedmont Health Research Institute
09.2009 - 01.2011
M.S. - Biology
Southern University
B.S. - Biology
Tuskegee University
Ph.D. -
Educational Leadership
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