Lead Consumer Safety Officer

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:

21st Century Cures Act Information

Introduction

The Food and Drug Administration is the federal agency responsible for protecting the public health by helping to ensure the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by helping to ensure the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.

The Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance public health through the regulation of biological and related products including blood, vaccines, allergenics, human tissues, and cellular and gene therapies. CBER protects and advances the public health by helping to ensure that biological products are safe, pure, and potent. CBER also provides the public with information to promote the safe and appropriate use of biological products.

OCBQ’s mission is to ensure the quality of products regulated by CBER over their entire lifecycle through pre-market review and inspection, and post-market review, surveillance, inspection, outreach and compliance.

Duties/Responsibilities –

The Lead Consumer Safety Officer (CSO) serves as a principal advisor to the Division Director and Branch Chiefs as appropriate and in biological product regulatory concerns related to the manufacturing process review. The incumbent plans, coordinates, and evaluates the overall review and approval process for Biologics License Applications (BLA), Premarket Applications (PMA), and other application types and supplements for biological products submitted to CBER. The Lead CSO concentrates on complex, long-range, and emerging problems and conflicts in the specific regulatory and scientific field as applicable to the products being regulated. The incumbent researches the application and associated problems in-depth and consults with other professionals, both within and outside CBER, as necessary, to resolve the issues. The Lead CSO devises solutions for unique, far-reaching, and previously unresolved problems.

Specifically, the Lead Consumer Safety Officer will:

• Provide guidance and training to reviewers in the division and branch.
• Conduct pre-license and pre-approval inspections of biological product manufacturing facilities as the lead CBER inspector.
• Evaluate and assess all sites to be potentially inspected, prepare reports of inspections and recommend appropriate follow-up based on the findings of the inspection.
• Develop and recommend new and revised guidelines for regulated products and determines areas of study for new or revised regulatory policy and guidelines.
• Recognize the need for and initiate new and amended regulations, policies, and procedures.
• Assure uniformity and consistency in the policies and procedures governing biological product review.
• Brief the Division Director, Deputy Division Director, Branch Chief, and other Center management, as well as the affected team member(s) on all scientific and regulatory interpretations and analyses affecting area of responsibility.

How to Apply

Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), a copy of your unofficial transcripts, SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OCBQ/DMPQ/MRB/Lead CSO” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through 10/4/24.

Announcement Contact

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

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

FDA is an equal opportunity employer.