Job Overview

Summary

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

 

The Food and Drug Administration (FDA) is a Federal scientific law enforcement agency with the legislated responsibility for ensuring that drugs, biological products and medical devices are safe and effective, that food and drugs are adequately packaged and informatively labeled and that radiation emitting devices are safe, and to prevent and reduce tobacco use. The work of the FDA is carried out by thousands of personnel stationed throughout the United States and abroad. The staff includes physicians, scientists, engineers and a variety of other multidisciplinary professional, technical and support personnel. FDA’s programs are national in scope and international in effect, and its activities directly affect and heavily impact upon multi-billion dollar industries, in addition to protecting the public health of hundreds of millions of American consumers.

This is a Senior Level (SL) executive position is located in the Food and Drug Administration, Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, Office of Partnerships in Silver Spring, MD.

Who May Apply: Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; and individuals with disabilities. YOU MUST SUBMIT YOUR SF-50 AND/OR DD FORM 214.

This position is located on the staff of the Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs (ORA). The Office of Regulatory Affairs plans and directs the management and administration of personnel and facilities to ensure the federal laws and regulations regarding FDA regulated products are enforced. ORA directs nationwide field operations that are performed by several thousand scientific, professional, regulatory and consumer safety personnel geographically dispersed throughout the nation and abroad; and manages state-of-the-art scientific laboratories strategically located throughout the U.S. and Puerto Rico.  The Director, Office of Partnerships serves as the principal advisor to the Associate Commissioner for Regulatory Affairs and Assistant Commissioner of Field Operations (ACFO) and provides overall leadership and guidance in the development, coordination, and evaluation of the Agency Federal-State program policy.  Serves as the senior ORA liaison to state/local/territorial/tribal partners on the implementation of the Food and Drug Administration Safety and Innovation Act (FDASI) and the Food Safety Manufacturer Act (FSMA).

 

Duties

As the Director, the incumbent provides counsel, leadership, and managerial direction necessary for effective accomplishment of the functional responsibilities:

A.           Serves as the principal advisor to the Deputy Associate Commissioner for Regulatory Affairs (DACRA) and the ACFO on all matters pertaining to federal-state activities, including identifying, prioritizing, evaluating and monitoring scientific research and analytical method development and validation projects in support of current and evolving FDA Foods Program business needs; and serves as a senior ORA liaison to state/local/territorial/tribal partners on food and feed safety issues.  Mitigates and responds to public health safety incidents through the development of partnerships, interagency agreements, and Memorandums of Understanding (MOUs).  Evaluates FDA and state/local inspectional findings, laboratory methodology, and sample results in search of gaps and equivalencies to effectuate maximum utilization of resources across FDA-regulatory programs. Collaborates with state/local agencies in pursuing mission-related laboratory analyses and research activities, investigations, and emergency operations.

B.           Directs the development and maintenance of agreements between FDA and its federal/state/local/tribal partners on research development, lab accreditation, and establishment of all-hazard Rapid Response Teams to respond to emergencies and associated with FDA-regulated products.

C.           Promotes public health safety protocols for humans and animals through enhanced laboratory methodologies, scientific research, epidemiological surveillance, streamlining and simplifying data sharing, and collaboration. This work is performed in close collaboration with several international and national science-based organizations.  Such organizations include Association of Food and Drug Officials (AFDO), Association of Public Health Laboratories (APHL), Association of American Feed Control Officials (AAFCO), Council of State and Territorial Epidemiologists (CSTE), and Council to Improve Foodborne Outbreak Response (CIFOR).  Develops and supports grants for the International Organization for Standardization (ISO) accreditation of state and federal food testing laboratories for microbiological and chemical food analysis. ISO accreditation provides general requirements for the competence of testing and calibration laboratories.

D.           Leads the development and implementation of national standards for Manufactured Food and working with retail standards, and the develop Animal Feed Standards. Ensures the consistent application of safety guidelines to prevent the spread of communicable diseases.

E.           Attends top level policy and planning conferences as a technical expert regarding State laws, leadership, capabilities and programs, and as official spokesperson for the field offices in State-Federal cooperative programs. Advises on the potential contribution and resource capabilities of state and local agencies to undertake nationwide or specialized programs and performs work in support of ongoing and proposed regulatory and surveillance programs.

F.            Plans, directs, and coordinates FDA, ORA and center liaison activities with national organizations of State and local and Federal officials whose interests correspond to those of FDA; i.e., National Association of Attorney Generals, health fraud coordination and State AIDS fraud task forces. Liaison activities include all forms of communications and all other activities deemed appropriate to support and improve mutual objectives.

G.           Provides professional guidance and counsel necessary to resolution of substantive problems associated with program activities. Reviews and approves, or disapproves, their recommendations regarding the content and/or agendas of material proposed for distribution to State of local agencies or to the field. Reviews and approves, or disapproves, recommendations of the field or the staff, concerning the commissioning of State and local officials.