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  1. CDER Offices and Divisions

Office of Quality Assurance

Who We Are

The Office of Quality Assurance (OQA), part of CDER’s super Office of Pharmaceutical Quality, equips staff with quality culture, education, and strategy to drive enterprise-level continual improvement of OPQ.

What We Do

  • Leads the development, implementation, and maintenance of the quality management system for The Office of Pharmaceutical Quality (OPQ).
  • Leads and manages the internal management review process and business processes for OPQ including developing key performance indicators for OPQ work products, processes, and services.
  • Oversees, tracks, and coordinates the design, development, and implementation of OPQ-specific training and developmental programs to ensure the skill sets and competencies of staff are maintained and continually improved.
  • Develops, implements, and maintains the Enterprise Risk Management System for OPQ.
  • Provides enterprise level program and project management support for OPQ for OPQ-wide initiatives, cross-cutting issues, strategic planning, and workload or staffing issues in a OPQ sub-office including supporting new initiatives and processes through l operationalization.
  • Coordinates information technology needs for OPQ and advocates for OPQ with Center and Agency level Information Technology (IT) groups and organizations.  Maintains the information technology strategic plan.

Office Organization

  • Learning & Professional Development Staff
  • Quality Assurance Staff 
  • Office of Quality Assurance Enterprise Project Management Staff


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