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Office of Program & Regulatory Operations

Who We Are:

The Office of Program and Regulatory Operations (OPRO) is a customer-oriented, regulatory-focused, and process-centered organization that leads OPQ's operational framework to foster collaboration, efficiency, and quality.

What We Do:

  • Leads and manages the regulatory and business processes, quality management system, and training and development system within the Office of Pharmaceutical Quality (OPQ).
  • Leads and manages all processes associated with drug quality assessments and facility inspections, for ANDA, BLA, NDA and manufacturing supplements, in collaboration with OPQ functional office leadership.
  • Designs, develops, and implements internal processes to support the drug quality assessments and inspections.
  • Leads the quality management system for OPQ which includes change management, document management, auditing, corrective and preventive actions, and nonconformance management.
  • Monitors, reports and leads corrective and preventive actions relating to the performance of internal processes, as defined by standard procedures.
  • Designs, develops, and implements OPQ-specific training and developmental programs to ensure the skill sets and competencies of staff are maintained and continually improved.
  • Provides project management for cross functional activities including drug shortage, integrated quality assessment, emerging technology program, OPQ speaker request, quality-related inquiries, and platform improvements. 

Office Organization:

These organizations report to the Office of Program and Regulatory Operations:

  • Division of Regulatory & Business Process Management I
  • Division of Regulatory & Business Process Management II
  • Division of Regulatory & Business Process Management III
  • Division of Operational Excellence, Learning & Professional Development

Office Leadership:                   

  • Director: Don Henry
  • Deputy Director: Vacant

Resources For You:

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