Director of Investigations Branch
Location(s): All FDA District Offices and Resident Posts in the following FDA Districts: New England, New York, New Jersey, Philadelphia, Baltimore, Cincinnati, Atlanta, Florida, San Juan, New Orleans
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:
The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured, packaged and regulated. 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 mission of the Office of Regulatory Affairs (ORA) is to protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.
To view our ORA Vision, Mission, and Values please visit:
The Office of Medical Products and Tobacco Operations (OMPTO) has responsibility for inspections, investigations, compliance and enforcement of medical products and tobacco facilities regulated by the Medical Product and Tobacco Centers. The incumbent is expected to have knowledge of ORA inspections of regulated products and manufacturers, provides expert advice and counsel to the Assistant Commissioner for Medical Products and compliance operations, training needs and emergency response activities related to advanced manufacturing and medical countermeasure regulated products.
Office of Biological Products Operations (OBPO) covers a wide range of products such as vaccines, blood and blood components, allergenics, gene therapies, human and animal cells, tissues, and cell- and tissue-based products, and recombinant therapeutic proteins. OBPO protects public health by assuring the safety, efficacy and quality of biological products and ensures that consumers have access to safe, high quality biological products by striving to be the world’s pre-eminent biologics inspectorate.
• Serves as Director of Investigations Branch overseeing Biological Product investigators based on program priorities : e.g., blood and blood products, HCTPs, NDA drug products and 510k/PMA devices regulated by CBER.
• Establishes programmatic objectives and resource support, internal/external relationships within the Agency and with industry and academia.
• Creates, reviews, and/or facilitates issuance of field assignments for biological products, monitors and serves as point of contact for these assignments.
• Plans, sets priorities, and schedules high priority and/or complex assignments having national and international significance.
• Monitors work plan performance and goal accomplishments.
Supervisory Responsibilities: As a second line supervisor the incumbent directs and manages the operations of the Investigations Branch with primary responsibility for providing leadership and guidance to first- line supervisors and subordinate employees. Supervisor provides occupational specific technical and administrative direction 25 percent or more of the time to three or more subordinate employees performing the work and functions of the organization.
How to Apply
Applications will be accepted from all qualified internal applicants. Please send letter of interest addressing your experience in the major duties and responsibilities of the position, resume/CV and bibliography, SF-50, transcript (with foreign credentials evaluation, if applicable) to the ORA Executive Recruitment and Scientific Staffing Committee, firstname.lastname@example.org. Applications will be accepted through November 29, 2022. Candidate resumes may be shared with hiring official within the OMPTO with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please reference Job Reference ID: OBPO Division I, Director of Investigations Branch (DIB).
For questions regarding this Cures position, please contact email@example.com.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.