Deputy Office Director for Import Operations

Summary:

The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Inspections and Investigations (OII), Office of Import Operations (OIO) and being filled under FDA’s Title 21 hiring authority. This hiring authority was passed by Congress in December 2016, to improve FDA’s ability to recruit and retain scientific, technical, and professional experts in certain occupational series that “support the development, review, and regulation of medical products.” The FY23 Omnibus Appropriations Bill expanded the hiring authority to include cross-cutting positions and individuals that support the development, review, and regulation of food and cosmetics in addition to medical products. Both statutes amended the FD&C Act 21 USC. This hiring authority is a streamlined hiring authority, outlined in 21 USC 379d-3a, as amended by the 21st Century Cures Act of 2016, § 3072 and the Consolidated Appropriations Act of 2023, § 3624.

This job is open to: Open to the Public

Hiring Path Clarification Text: You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Duties

The Deputy Office Director for Import Operations (DDIO), in his/her capacity serves as the principal advisor to the Assistant Commissioner for Import Operations (ACIO) and the Associate Commissioner for Inspections and Investigations (ACII) for operational direction. In addition, the incumbent serves as the supervisor of the following Import Divisions: Southwest Imports, Southeast Imports, Northeast Imports, Northern Border Imports, and West Coast Imports.

Supervisory Responsibilities: The DDIO closely shares with the ACIO in providing executive leadership in the development, implementation and evaluation of regulations and policies as they relate to OII's broad national and import programs and activities to ensure the safety of FDA-regulated products. Additionally, the incumbent:

• Oversees the implementation of the enforcement policy of the Food Safety Modernization Act (FSMA) mandates, which safeguards the safety of imported FDA- regulated food and feed products. For example, the DDIO will have direct oversight of new FDA food safety innovations like the Foreign Supplier Verification Program (FSVP), and certification programs to ensure imported FDA-regulated food and feed products are produced in compliance with FDA laws and regulations.

• Enhances transparency initiatives for sharing compliance information and enforcement data to promote better risk-based product approaches both domestically and internationally.

• Provides leadership and direction on the application of risk management and program evaluation techniques to regulatory compliance activities so that limited resources can provide the most public health promotion/protection at the least cost to the public.

• Works closely with Agency risk management and program evaluation experts, including those in the Centers and the Commissioner's Office, to identify opportunities for enhanced coordination and better approaches to identifying, prioritizing, and managing risk through compliance programs and enhanced collaboration within FDA and counterpart governmental agencies, domestically and abroad, and other interested stakeholders.

Working in coordination with the ACIO, the DDIO:

• Negotiates the multi-year work plan covering both planned and unplanned work between the program manager and the Centers which is binding on both parties to carry out unless and until it is modified with the agreement of both parties.

• For planned work: Works with the Centers to identify the nature, quantity and geographic location of the work that needs to be done and can be planned. These would include such diverse and critical activities as surveillance inspections, for cause inspections, import review and sample collections, and laboratory testing and applied research needs.

• For unplanned work: Designs, develops and implements plans that provide estimates for emerging public health concerns such as: preapproval inspections, investigating complaints, and required investigations of incidents that suggest Federal Food, Drug, and Cosmetic Act (FD&C Act) violations and/or public health concerns.

Work Plan Execution Management:

• Represents OII in joint monitoring of the execution of the import work plan and, in consultation with the ACII, negotiates on behalf of OII any necessary adjustments required throughout the year.

• Monitors performance for adherence to plan; and takes corrective action to course correct as necessary.

• Negotiates modifications to plans and agreements for OII with the Centers as needed and ensures all impacted OII parties are informed of changes in a timely manner.

Workforce Development and Training:

• Ensures that training of specialized staff for the import program meets current and future needs through continuing education. Assures consistency of performance standards for import inspectors and compliance officers and a level of expertise consistent across the Centers.

• Designs and develops, in consultation with the ACIO, ACII, Principal Deputy ACII and other OII leadership on long range strategic, scientific, and tactical plans for the specialization of OII resources including investigational staff and compliance staff to meet the Office/Centers current and future needs. Then manages, working with OII’s OTED, in the implementation of those needs in OII including recruitment and training/retraining needs.

• Serves as the import program focal point and expert for the long-term change process of moving OII to a program/product alignment of resources to assure that FDA speaks with one voice on import regulatory programs, all the while assuring that year-by-year existing structures implement the public health risk-based priorities of the import program. Under the incumbent's guidance and oversight the will eventually be transformed into specialized units within OII operating in program-based staffs and will be directed and managed by commodity-specific offices and in the case of imports be led by this incumbent.

Budget Formulation and Execution of Import Resources:

• Participates in the formulation of the OII import budget request in concert with the Centers and OII’S Office Management (OM) to assure OII's total import needs are represented and justified. Monitors the formulation process and supports OII on all import matters pertaining to the budget formulation process advising OII officials when they are negotiating at the FDA, DHHS, OM and Budget (OMB) and Congressional levels regarding export action planning items.

• Works with OM and other OII leadership monitors the budget execution of the import

program resources to assure conformance with Congressional and OMB allocations.

• Represents and speaks for the ACIO and ACII in discussions, meetings, conferences, and

consultations with top-level departmental and agency officials, national/international

industry representatives, academic organizations and groups, foreign officials, members

of Congress and/or their representatives, personnel from other executive departments

and independent Federal agencies, State and local governmental counterparts and

others to secure and provide information concerning critical and significant issues,

actions and regulatory activities related to OII programs and to resolve complex

regulatory questions and issues that arise.

How to Apply

Applications will be accepted by all qualified candidates. United States Citizenship is required. Please submit a letter of interest addressing your experience in the major duties and responsibilities of the position, a detailed current resume, and college transcript(s) (with foreign credentials, if applicable) showing degree was awarded (a diploma will not be accepted as part of your application) to: OIIExecutiveandScientificHiring@fda.hhs.gov.

Applications will be accepted through December 9th, 2024.

Applicants must reference the job ID: 4-OIO-DDIO-G in the email subject line.

NOTE: It is the applicant’s responsibility to ensure the job ID is noted in the subject line and the appropriate required documentation is submitted prior to the closing date for the application to be considered.

Announcement Contact

For questions regarding this Title 21 position, please contact OIIExecutiveandScientificHiring@fda.hhs.gov and include the following job reference ID in the subject line: 4-OIO-DDIO-G-Q