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: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

Introduction

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 Human Foods Program (HFP) is to protect and promote the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe.

Duties/Responsibilities

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 is responsible for evaluating and making fitness-for-use determinations of food safety systems and also making recommendations to HFP leadership on maximizing domestic and international regulatory partners’ food safety work to increase 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:

• Provides executive-level management, leadership, and consultation on HFP’s quality management system and assessments program; ensures that quality standards and audits and assessments following consistent practices.

• Creates and implements quality assessment and management practices, policies, and procedures to align with the organization’s goals and objectives.

• Leads the formulation of audit activities and programs. Ensures that inspection, investigation, sample collection and analysis, enforcement, response recovery and outreach components meet programmatic standards.

• Serves as principal advisor to the Deputy Commissioner, HFP leadership, and Agency leadership on all matters concerning quality management and assessment programs, standards, and policies. Serves as an expert advisor on ISO accreditation requirements and activities.

• Leads innovative approaches on leveraging external (state/international) food safety systems to inform risk prioritization in collaboration with other HFP offices.

• Leads the collaboration with other HFP offices and the development of training for HFP staff to ensure that quality standards are integrated into all aspects of the organization.

• Assesses current internal processes and procedures to identify inefficiencies and opportunities for improvement. Oversee the implementation of process improvements

based on assessment findings, ensuring changes enhance quality and performance. Identify potential risks related to quality and develop mitigation strategies to minimize their impact. • Keeps abreast of industry trends, standards, and best practices to ensure that the organization's QA practices remain current and effective.

• Establishes and maintains liaisons throughout HFP, within FDA and Department of Health and Human Services (HHS), State, local, and international regulatory partners, and key representatives from agencies and programs for which the office conducts business to inform and explain regulations and audit procedures and processes.

• Participates in and contributes to top level HFP, Agency, and Department discussions, meetings, and conferences on matters and issues concerning HFP’s quality management system and assessments program. Monitors, coordinates, and advises the Deputy Commissioner, HFP leadership, and staff on new and revised policies.

• Ensures that the organizational structure of the Office provides for uniformity, optimum effectiveness, and operational efficiency. Analyzes and defines significant obstacles to program accomplishments and recommends changes and initiates action to ensure effective resource utilization and the elimination of unnecessary duplication. Promotes and encourages intra- and inter-program cooperation to achieve program objectives.

• Manages the personnel and financial resources of the Office ensuring that resources are allocated and utilized in accordance with the identified priorities and core functions of the HFP.

Supervisory Responsibilities:

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. * 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 equal opportunity in all Federal human capital and employment programs regardless of race, color, gender, national origin, religion, age, disability, genetic information, sexual orientation, affiliation or non-affiliation with a labor organization, political affiliation, status as a parent. * Provides employees resources and information that insures a safe and healthy work environment.

How to Apply

How to Apply: Submit resume or curriculum vitae with cover letter and a copy of all transcripts (with foreign credential evaluation, if applicable) by the closing date as identified above to hfpexecutiveresources@fda.hhs.gov. Candidate resumes may be shared with hiring official within the CFSAN with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. For questions please contact hfpexecutiveresources@fda.hhs.gov. Please reference Job Reference ID: OQAM, Office Director.

Announcement Contact

For questions regarding this Cures position, please contact hfpexecutiveresources@fda.hhs.gov. Please reference Job Reference ID: OQAM, Office Director.

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.

FDA is an equal opportunity employer.