Summary:

The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) Office of Medical Products and Tobacco Operations (OMPTO), Office of Pharmaceutical Quality Operations (OPQO) 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.

Learn More About This Agency:

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! HHS 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 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 U.S. are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated.

The mission of the Office of Regulatory Affairs (ORA) is to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs.

The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 12 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.

The Office of Pharmaceutical Quality Operations (OPQO) is specialized to help protect and promote the safety and quality of human and animal products. This program, within the Office of Medical Products and Tobacco Operations (OMPTO), provides advice and counsel to ORA and FDA leaders regarding pharmaceutical products, field operations, and emergency response activities. OPQO collaborates with the agency’s Center for Drug Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM) on all FDA-regulated pharmaceutical and biopharmaceutical products.

Title 21 Pay Table 1, Band F/>GS-15 equivalent

Minimum – $181,551

Maximum – $260,823

Overview

Open & Closing Date: August 28, 2024 – September 11, 2024

Salary Range: $181,551 - $260,823

Band: AD-F (>GS-15 equivalent)

Occupational Series: 0696

Duty Location: Various locations

Remote Job: No

Telework Eligible: Determined upon selection

Travel Required: Up to 25%

Relocation Expenses Reimbursed: No

Appointment Type: Permanent

Work Schedule: Full Time

Competitive Service: Yes

Promotion Potential: Band F

Supervisory Status: This is a supervisory role

Security Clearance: Secret

Drug Test: Yes

Position Designation: Non-Critical Sensitive/High Risk /Tier 5/High Tier/SF 86

Trust Determination Process: Suitability/Fitness

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 Field Operations (DOD-FO or Deputy) assists the Office Director, OPQO and is empowered to exercise full authority in the absence of the Director. This involves the advancing of regulatory programs, promoting an understanding of FDA's responsibilities for enforcing regulatory standards to protect and promote public health, actions and activities related to FDA pharmaceutical inspection operations, and resolving complex technical and/or scientific questions and issues that arise. The Deputy, along with the Director, is directly responsible for providing leadership to employees who are engaged in inspectional and compliance activities related to the program area. The Deputy shares fully with the Director and Deputy Office Director (Strategic Oversight), in the facilitation of office staff coordination between multiple, smaller field divisions. As an advisor to the Director, the incumbent is expected to assist with development of inspectional and compliance related guidance; provide scientific and technical direction; advise and represent the Director; provide leadership to subordinates and oversight of operations; coordinate advanced training opportunities; serve as liaison/coordinator with field offices; and develop short/long term goals for the Center.

The DOD-FO participates fully with the Director in planning, managing, organizing, and directing all the field activities of the organization through subordinate supervisors and/or team leaders and a highly trained and skilled staff of professional supervisors and subject matter experts in a variety of professional, administrative, and support staff occupations organized into subordinate organizations. The incumbent shares the Director’s responsibility for assuring the efficient operation of the Office, including adequacy of on-the- job training, assignments, and performance of personnel. The Deputy provides oversight and technical guidance to programs and activities related to pharmaceutical field operations and inspections. In conjunction with the Director, the DOD-FO serves as the agency’s authoritative consultant and focal point for ORA and personnel of state, local, tribal, and international regulatory agencies in planning and implementing necessary efforts related to the pharmaceutical program. As delegated, the Deputy represents and speaks for the Director in meetings with agency and state officials in matters related to operations administered by ORA.

The Deputy Office Director represents ORA in joint development, monitoring, and the execution of the program work plan and, in consultation with the Director, negotiates on behalf of ORA any necessary adjustments required throughout the year. The Deputy monitors performance for adherence to plans and negotiates modifications to plans and agreements for ORA as needed and assures all impacted ORA parties are informed of changes in a timely manner. In consultation with the Director and other ORA leadership, the Deputy develops long-range strategic, scientific, and tactical plans for specialization of ORA resources including inspectional staff and compliance staff to meet ORA’s current and future needs.

Supervisory Responsibilities: Manages a functional discipline. The incumbent is required to: exercise delegated managerial authority to set a series of annual, multiyear, or similar types of long-range work plans and schedules for in-service or contracted work. The DOD-FO assures implementation (by lower and subordinate organizational units or others) of the goals and objectives for the program segment(s) or function(s) they oversee. The Deputy determines goals and objectives that need additional emphasis; determines the best approach or solution for resolving budget shortages; and plans for long-range staffing needs, including such matters as whether to contract out work. Additionally, the Deputy works closely with high level program officials (or comparable agency level staff personnel) in the development of overall goals and objectives for assigned staff function(s), program(s), or program segment(s).

Requirements

How to Apply

Applications will be accepted by all qualified applicants. United States Citizenship is required. Applicants must submit a detailed current resume, and college transcript(s) showing degree was awarded (with foreign credentials evaluation if applicable). A diploma will not be accepted as part of your application. All required materials should be sent to:

ORAExecutiveandScientificRecruitment@fda.hhs.gov. Applications will be accepted through September 11, 2024.

IMPORTANT: Applicants must reference: 4-OPQO-DOD-FO-F in the email subject line.

Announcement Contact

For questions regarding this Title 21 position, please contact ORAExecutiveandScientificRecruitment@fda.hhs.gov and include the following job reference ID in the subject line: 4-OPQO-DOD-FO-F-Q