Regulatory Focus™ > News Articles > Leader Sought for FDA's Powerful New Office of Pharmaceutical Quality

Leader Sought for FDA's Powerful New Office of Pharmaceutical Quality

Posted 02 April 2015 | By Alexander Gaffney, RAC

Leader Sought for FDA's Powerful New Office of Pharmaceutical Quality

The US Food and Drug Administration (FDA) has big plans to boost the quality of pharmaceutical products through the creation of its new Office of Pharmaceutical Quality (OPQ). But its success perhaps depends on one factor more than any other: Finding the right person to lead the effort.


The creation of OPQ was first announced in September 2012 during a larger reorganization of the Center for Drug Evaluation and Research (CDER) by longtime Director Janet Woodcock.

"Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety," said Woodcock in a 2012 memo to FDA staff. "We must be strategic and have systems in place to identify and respond to quality issues before they become problems. This is especially critical due to the global nature of drug manufacturing and the sourcing of raw materials outside of the US."

OPQ was envisioned by Woodcock as a way to oversee drug quality throughout the product lifecycle, instead of the fragmented pre-market/post-market approach now taken by CDER. Accordingly, Woodcock announced that the Office of Pharmaceutical Science (OPS), Office of Generic Drugs (OGD), Office of Manufacturing and Product Quality (OMPQ) and Office of Compliance (OC) would all be ceding some of their quality functions to OPQ.

OPQ is also meant to address several endemic problems in the pharmaceutical sector, Woodcock has explained. Chronic drug shortages and a lack of manufacturing modernization have both factored into FDA's decision to create OPQ, Woodcock told Regulatory Focus in January 2015.

Since OPQ's formal launch in January 2015, the office has been reviewing the quality sections of all new and abbreviated new drug applications (NDAs/ANDAs), and is working on ways to move the pharmaceutical industry toward improved quality manufacturing practices.

Read more about the launch and goals of OPQ here.

Searching for a Director

To date, OPQ has been overseen by Woodcock with assistance from OPQ Deputy Director Lawrence Yu, who was formerly the acting director of CDER's Office of Pharmaceutical Science.

Now, though, CDER is on the hunt for a permanent director for OPQ.

In a statement emailed to Regulatory Focus this week, CDER says it's looking for someone who can act as a "key contributor" on policy matters and issues related to pharmaceutical quality, as well as someone who can design and develop new policies, plans, research and regulations related to drug quality.

The notice explains the OPQ director will oversee a staff of more than 1,000. Candidates are expected to have a doctoral level degree, "extensive knowledge of drug manufacturing and quality," and working knowledge of quality regulations and guidelines.

CDER also appears to be working hard to attract a highly qualified candidate for the position. The hiring notice explains hires will be paid "commensurate with education and experience," and that the position will be eligible for up to a quarter million dollars in base pay.

The position will be open for applications between 1 April and 14 April 2015. Interested parties can contact to apply.

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