Who We Are
The Office of Manufacturing Quality (OMQ) evaluates compliance with manufacturing requirements for drugs based on inspection reports and evidence gathered by FDA investigators. OMQ develops and implements compliance policy and takes risk-based actions to protect the public from adulterated drugs in the U.S. market.
The Office of Manufacturing Quality (OMQ) is currently recruiting for regulatory positions within multiple locations in the office.
What We Do
- Develop and implement compliance and enforcement policies and actions to protect patients from products that are produced under conditions that may pose a risk to public health.
- Work to bring inspected facilities with significant violations of federal laws and regulations into compliance through warning letters and other actions.
- Collaborate with FDA investigators to ensure the uniform application of risk-based, patient-focused compliance and enforcement policies and actions.
- Evaluate manufacturing and product quality issues to mitigate and prevent drug shortages.
- Division of Drug Quality I
- Division of Drug Quality II
- Manufacturing Quality Guidance and Policy Staff
Office of Manufacturing Quality Recruitment Program
OMQ employs technical staff in a wide variety of fields and disciplines, including biologists, chemists, microbiologists, engineers, former FDA investigators, and others with technical expertise in current good manufacturing practice requirements (CGMPs). OMQ also employs regulatory counsels with experience or are interested in compliance/regulatory issues related to the manufacturing of drugs.
OMQ is interested in recruiting qualified candidates, including those with CGMP experience in the manufacture of drugs. Working in OMQ provides an exceptional way to gain experience in drug manufacturing, quality assurance, quality control, regulatory compliance, enforcement, and CGMP compliance policy.
New hires are trained by senior technical staff and collaborate with other FDA offices on an ongoing basis. OMQ leads the evaluation of noncompliant human drug manufacturing and plays a key role to protect the American public by taking action against violative drug manufacturers.
Opportunities for Students and Recent Graduates
The Office of Manufacturing Quality participates in the Oak Ridge Institute for Science and Education (ORISE) Research Participation Training Program. The goal of this program is to provide practical scientific training for scientists and physicians through the performance of scientific projects at the FDA. All of the projects will be relevant to the mission of the FDA. Additional information may be obtained here.
Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 4337
Silver Spring, MD 20993-0002
- Warning Letters
- GDUFA III Changes for Facilities: To request a post-warning letter meeting or reinspection under the terms of the GDUFA III commitment letter, contact FDA-GDUFAIII-PostWarningLetterandReinspectionRequests@fda.hhs.gov. Requesters should ensure they meet the criteria for post-warning letter meetings and generic drug facility reinspection and include in their request a list and status of all corrective and preventative actions (CAPAs).
- Current Good Manufacturing Practice (CGMP) Regulations