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Office of Manufacturing Quality

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.

Organization

  • 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 (CGMP) requirements. 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.

Citizenship is a requirement for permanent positions in the government. Information on employment with the Food and Drug Administration is available on both the FDA and CDER web sites.

Contact Us

Email: cder-oc-omq-communications@fda.hhs.gov 

Phone: 240-402-0990

Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 4337
Silver Spring, MD 20993-0002 

Additional Resources

Presentations and Publications by Office of Manufacturing Quality Staff

Our staff conducts research, publishes articles, and presents on pharmaceutical manufacturing topics.

Publications

Allison G, Cain YT, Cooney C, Garcia T, Bizjak TG, Holte O, Jagota N, Komas B, Korakianiti E, Kourti D, Madurawe R, Morefield E, Montgomry F, Nasr M, Randolph W, Robert JL, Rudd D, Zezza D. Regulatory and quality considerations for continuous manufacturing. May 20–21, 2014 continuous manufacturing symposium. J Pharm Sci. 2015 Mar;104(3):803-812. doi: 10.1002/jps.24324. Epub 2016 Jan 8. PMID: 28756842.

Friedman RL. Aseptic processing contamination case studies and the pharmaceutical quality system. PDA J Pharm Sci Technol. 2005 Mar-Apr;59(2):118-26. PMID: 15971544.

Friedman RL. Modern Quality Systems. In: Prince R, editor. Microbiology in Pharmaceutical Manufacturing. 2nd ed. Vol. 2. Bethesda, MD: Parenteral Drug Association; 2008. p. 335-376.

Friedman, RL, Mahoney S. Risk factors in aseptic processing. Am Pharm Rev. 2003;6:44-47.

Friedman RL. Using QRM to assure lifecycle processes, equipment, and facility improvement. Inst Valid Technol. 2015 Dec 21. Epub 2015 Dec 21.

Glowicz J, Crist M, Gould C, Moulton-Meissner H, Noble-Wang J, de Man TJB, Perry KA, Miller Z, Yang WC, Langille S, Ross J, Garcia B, Kim J, Epson E, Black S, Pacilli M, LiPuma JJ, Fagan R; B. cepacia Investigation Workgroup. A multistate investigation of health care-associated Burkholderia cepacia complex infections related to liquid docusate sodium contamination, January-October 2016. Am J Infect Control. 2018 Jun;46(6):649-655. doi: 10.1016/j.ajic.2017.11.018. Epub 2018 Jan 9. PMID: 29329922.

Pawar P, Talwar S, Reddy D, Bandi CK, Wu H, Sowrirajan K, Friedman R, Drazer G, Drennan JK 3rd, Muzzio FJ. A “Large-N” content uniformity process analytical technology (PAT) method for phenytoin sodium tablets. J Pharm Sci. 2019 Jan;108(1):494-505. doi: 10.1016/j.xphs.2018.06.031. 

Seelman SL, Bazaco MC, Wellman A, Hardy C, Fatica MK, Huang MJ, Brown AM, Garner K, Yang WC, Norris C, Moulton-Meissner H, Paoline J, Bicking Kinsey C, Kim JJ, Kim M, Terashita D, Mehr J, Crosby AJ, Viazis S, Crist MB. Burkholderia cepacia complex outbreak linked to a no-rinse cleansing foam product, United States - 2017-2018. Epidemiol Infect. 2022 Aug 4;150:e154. doi: 10.1017/S0950268822000668. PMID: 35923078.

Szymczak MM, Friedman RL, Uppoor R, Yacobi A. Detection, measurement, and control in pharma manufacturing. Pharm Technol. 2011 Oct;35:70-76.

Talwar S, Pawar P, Wu H, Sowrirajan K, Wu S, Igne B, Friedman R, Muzzio FJ, Drennen JK 3rd. NIR spectroscopy as an online PAT tool for a narrow therapeutic index drug: Toward a platform approach across lab and pilot scales for development of a powder blending monitoring method and endpoint determination. AAPS J. 2022 Sep 28;24(6):103. doi: 10.1208/s12248-022-00748-4. PMID: 36171513.

Yang WC. Mammalian fed‐batch cell culture for biopharmaceuticals. In: Cell Culture Engineering: Recombinant Protein Production. Lee GM, Kildegaard HF, Lee SY, Nielsen J, Stephanopolous G, editors. 1st ed. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co. KGaA; 2019. p. 313-345. doi: 10.1002/9783527811410.ch13.



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