Summary

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 4, Band G.

Duties

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• The Office of Quality Assessment and Management (OQAM) leads the quality initiative for the Human Foods Program (HFP), supporting a culture of continuous improvement and optimization of program operations.
• The Office evaluates food safety systems for fitness-for-use and advises HFP leadership on leveraging domestic and international regulatory partners' food safety efforts to strengthen public health protection.
• OQAM also assesses and monitors the efficacy and efficiency of HFP programs and procedures and makes recommendations to HFP leadership of options for improvement.
• The Office Director manages the Quality Assessment Staff and Quality Management Staff and performs the following:
• Serves as the principal scientific and policy advisor to the Deputy Commissioner for Food, and Agency leadership on quality management, assessment programs, standards, and policies that support food safety, nutrition, and public health protection.
• Responsible for the overall planning and evaluation of Office of Quality Assessment and Management (OQAM) programs.
• Reviews and makes recommendations regarding budget allocation, spending, personnel requests and proposals. Plans and implements improvements to better carry out the mission of OQAM and HFP.
• Plans and implements improvements to better carry out the mission of OQAM and HFP.
• Applies advanced knowledge of health science principles, and food safety methodologies to ensure that quality standards, audits, and assessments are conducted following consistent, scientifically sound practices.
• Creates and implements evidence-based quality assurance strategies and policies aligned with organizational goals, using expertise in public health science, epidemiology, and food safety risk principles to evaluate program effectiveness.
• Applies expert knowledge of health science disciplines, including related science, and/or epidemiology to advise leadership on complex scientific questions with significant public health implications.
• Expert advisor on ISO accreditation, leading quality management, assurance, strategic planning, and performance excellence programs. Uses health science data, research, and literature to identify gaps and recommend evidence-based policy solutions.
• Applies expert knowledge of health sciences, related scientific fields, and epidemiology to advise leadership on complex scientific issues with significant public health implications.
• Serves as the Agency's expert advisor on ISO accreditation requirements and activities, overseeing the development and implementation of policies, programs, strategic quality planning, quality assurance, and performance excellence initiatives.
• Defines and monitors key performance indicators (KPIs) to assess quality assurance effectiveness, using analytical and epidemiological methods to identify improvement opportunities and evaluate public health outcomes.
• Assesses processes and procedures to identify inefficiencies and improvement opportunities, applying expertise in food safety systems, Good Manufacturing Practices (GMPs), and Hazard Analysis and Critical Control Points (HACCP) principles.
• Monitors industry trends, emerging scientific standards, and best practices in food safety, nutrition science, and public health to ensure quality assurance practices remain current, scientifically sound, and effective.

Requirements

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Conditions of employment

Ethics Clearance Requirements

This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

Qualifications

In order to qualify for the Office Director, Office of Quality Assessment and Management position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/30/2026:

The candidate must meet the following qualifications for this Title 21 position:

1. Scientific, Technical, and/or Professional Fields
2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions

b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

Technical Qualifications: Candidates do not need to provide narrative responses. However, the technical qualifications must be reflected within the candidate's two-page resume.

• At least 5 years of experience leading teams or work related to quality management and assurance with demonstrated success in building a quality culture focused on driving continuous improvement within an complex organization.
• Demonstrated ability to analyze business processes and procedures, identify root causes, generate corrective/preventive actions, and oversee and evaluate the process improvement effort.
• Demonstrated ability developing networks and building alliances with internal and external parties; collaborating across boundaries to build strategic relationships and achieve common goals.

Desired Qualifications: At least 5 years of experience, or equivalent, providing executive-level leadership in the following areas:

• Familiarity with a variety of technology solutions, such as automation and artificial intelligence, that support the optimization and improvement of program operations.
• Experience communicating highly technical information in a clear way and working with staff at all levels of the organization and varying levels of domain expertise.

This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

Supervisory Responsibilities:

• The incumbent 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.
• Obtains resources and identifies strategic objectives for the organization.
• Defines jobs, selects employees, and assigns work; defines technical work requirements and milestones; evaluates the organization and employee accomplishments by accepting or rejecting work products; and presents and defends organization and employees work to senior management and other offices.
• Recommends employee promotions and recognition; approves leave; implements performance modifications and takes corrective actions as appropriate.
• Provides employees with resources and information that ensure a safe and healthy work environment.

Conditions of Employment:

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to random, reasonable suspicion, and post-accident drug testing upon hiring.
• Appointment to the position will be contingent upon a negative applicant drug test result.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• Pre-employment physical required: No
• Drug testing required: No
• License required: No
• Mobility agreement required: No
• Immunization required: No
• Bargaining Unit: No
• Telework eligible position: Telework is at the discretion of the supervisor.

Education

Education Requirements:

Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education(external link) at the time the degree was obtained.

https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/general-medical-and-healthcare-series-0601/

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

TRANSCRIPTS (Required): Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the In