In order to improve the oversight of quality in the pharmaceutical industry, the US Food and Drug Administration (FDA) launched the Office of Pharmaceutical Quality (OPQ) in January, combining all non-enforcement related drug quality work.
Last week Janet Woodcock – Director of the Center for Drug Evaluation and Research (CDER) – sent a memo announcing the agency had begun recruiting for the permanent Director of the new “super office,” calling for those looking to lead the CDER in matters related to the regulation of pharmaceutical quality to apply before April 14.
“OPQ was designed to address the challenges of globalization, increased technical complexity of manufacturing, and the need to use advance information technology to monitor quality instead of periodic inspections alone,” FDA spokesman Kristofer Baumgartner told in-Pharmatechnologist.com.
“The OPQ Director’s job will be to maintain the forward momentum in all of these areas."
He added the immediate issues facing the new Director “will be to continue to make strong progress to reduce and eliminate the generic drug application backlog, continue to implement the GDUFA program, and continue to lead the integration of the review, inspection, and compliance functions in order to streamline the process.”
As to the ideal candidate’s qualifications, he/she must hold a doctorate, be experienced with pharmaceuticals – or closely related – manufacturing, and have at least 10-15 years of involvement in pharmaceutical quality, operations, technical services and related areas.
If – like this reporter – you don’t quite fit the above criteria, Baumgartner said there are about 100 other vacancies currently at the OPQ. “[The Agency] will be focusing on recruiting the necessary staff to fulfil its mission. Staff levels may be adjusted as workload is analysed periodically.”
Organisational Structure
When first announced last year, Woodcock said the “office will provide internal customers with a single drug quality assessment that captures the overall OPQ recommendation on approvability, and OPQ will provide feedback on quality deficiencies earlier in the review cycle.”
Furthermore the organizational structure is intended to ensure that “safe, effective, high quality drugs are available for the American public,” and includes the incorporation of the following offices:
- Office of Program and Regulatory Operations (OPRO)
- Office of Policy for Pharmaceutical Quality (OPPQ)
- Office of Biotechnology Products (OBP)
- Office of New Drug Products (ONDP)
- Office of Lifecycle Drug Products (OLDP)
- Office of Testing and Research (OTR)
- Office of Process and Facilities (OPF)
- Office of Surveillance (OS)