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FDA Data Analytics for CGMP Compliance: Evaluating Regulatory Action Patterns

Oak Ridge Institute for Science and Education · White Oak, MD · 3 wk ago
AnalystFull-time

About the role

The FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in White Oak, Maryland.

Research Project

You will engage in a comprehensive research initiative focused on analyzing current good manufacturing practice (CGMP) drug regulatory actions (warning letters, import alerts, regulatory meetings, consent decrees) and their outcomes to enhance public health protection. You will investigate the landscape of compliance actions against pharmaceutical firms that violate CGMP regulations, with particular emphasis on understanding the relationship between enforcement timeframes and public health outcomes.

You will collaborate with OMQ staff to research and analyze data from FDA's internal compliance management system, with both structured and unstructured datasets. Key activities include investigating patterns in regulatory actions, analyzing temporal relationships between enforcement activities and compliance outcomes, and contributing to the development of evidence-based insights that inform enforcement policy development and process improvement initiatives.

Learning Objectives

  • Participate in comprehensive training on CGMP regulations, policies, and enforcement procedures
  • Investigate the regulatory framework governing pharmaceutical manufacturing quality
  • Research enforcement tools available to OMQ and their appropriate applications
  • Analyze complex datasets using Excel, PowerBI, and other analytical platforms
  • Participate in data manipulation and validation exercises across multiple database systems
  • Contribute to the development of data visualization and reporting methodologies
  • Collaborate on research design for compliance outcome studies
  • Investigate statistical methods for analyzing regulatory action effectiveness
  • Participate in structured approaches to synthesizing findings from diverse data sources

Participant Stipend

The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements

This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

Mentor

The mentor for this opportunity is Tri Le (tri.le@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

The anticipated appointment start date is September 14, 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length

The appointment will initially be for eight months, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation

The appointment is full time.

Qualifications

  • Citizenship: LPR or U.S. Citizen
  • Degree: Associate's Degree, Bachelor's Degree, Master's Degree, or Doctoral Degree.
  • Discipline(s): Relevant field.

Questions

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

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