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This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here:

 

Introduction

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

 

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates the over the counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.

 

The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products.

 

The Offices of Product Quality Assessment (OPQA) III evaluate and assess product quality aspects over the product lifecycle for all types of human drug product applications, including Investigational New Drugs (INDs), Biologics Licensing Applications (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Active Pharmaceutical Ingredients (API) information supporting these applications, and make risk-informed recommendations on the approvability of such products and evaluates and assesses post-marketing activities for these drug products.

 

Duties/Responsibilities

As a Division Director, the incumbent plans and directs activities and oversees the scientific review and quality evaluation of applications assigned to the Division. Advises Office of Pharmaceutical Quality OPQ,CDER, and other Centers (including Office of Regulatory Affairs) on scientific and regulatory issues associated with pharmaceutical quality.

 

  • Directs the evaluation and assessment of pre-marketing and post-marketing activities for INDs, BLAs, NDAs, or ANDAs; and monitors, oversees, and coordinates the performance of team-based reviews that include cross-office collaboration and participation in inspections.
  • Develops and oversees the execution of strategies involving application review and ensures the consistency of regulatory decisions.
  • Develops and oversees the execution of strategies involving the pre- and post-approval assessments.
  • Directors the operational management of the division, including budget, hiring, and training of staff.

 

Supervisory Responsibilities: Provides leadership and management oversight to subordinate staff. Supervises and evaluates staff supervisors who serve as experts in their field. Provides occupational specific technical and administrative direction and supervision 25 percent or more of the time to subordinate staff performing the work and functions of the organizational unit. Reviews and approves or disapproves subordinate supervisors and staff’s leave requests. Obtains and identifies strategic objectives for the organization.

 

How to Apply

All qualified candidates will access a virtual interview platform via HireVue where you will be directed to record answers to screening questions. Recordings to all questions must be complete before the conclusion of the announcement period for application packages to be considered completed. Your recorded answers and resume should be uploaded to your HireVue profile by February 9, 2024.

 

Please send copies of your transcripts to OPQ_Cures_Recruitment@fda.hhs.gov not later than February 9, 2024. If you have foreign transcripts, please submit the foreign transcript course-by-course evaluation from an accredited company (NACES or AICE). Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.

 

Please reference Job Reference: OPQAIII Division Director in the email subject line.

 

How You Will Be Evaluated

Candidates may be evaluated based on an interview, review of requested work samples, writing samples, most recent performance evaluation(s), professional references, results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Announcement Contact

For questions regarding this Cures position, please contact OPQ_Cures_Recruitment@fda.hhs.gov.

 

The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

 

FDA is an equal opportunity employer.