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.
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
- Director: Don Henry
- Deputy Director: Vacant