Clarification from the agency

Those applicants who meet the mandatory qualifications of the announcement.

• Provides executive leadership, direction, and senior management for all of the Center’s compliance and enforcement responsibilities regarding the planning, development, administration, execution, and coordination of nationwide programs and policies.
• Provides executive leadership and direction for all retail regulatory projects and tobacco retail investigations, inspections, and enforcement action reviews.
• Oversees the office’s policies, priorities, and processes for all advisory, administrative, and judicial enforcement actions, including issuing warning letters, civil money penalties, injunctions, seizures, import alerts, and no tobacco sales orders.
• Provides direction, leadership, coordination, and guidance for the overall operations of program segments responsible for all compliance and enforcement policy issues and the Office of Compliance and Enforcement (OCE) extensive contracts program.
• Plans and sets long-range goals and schedules for the overall work of the Office, ensures implementation by the management team for the Office and organizes the goals, priorities, and objectives of the Office.
• Determines goals and objectives that need additional emphasis, determines the best approach and solution for resolving budget problems, and plans for long-range staffing needs.
• Establishes, prioritizes, and approves OCE quality management activities, as well as determines key business processes.
• Performs review and analysis of data to ensure continued suitability, adequacy, and effectiveness of OCE products, services, and systems.
• Performs a critical role in strategic planning activities for OCE and guides the strategic vision for the office.
• Guides the Office’s strategic vision, including assignment of resources to strategic program areas in order to generate maximum impact and mission achievement.
• Sets priorities for Office program areas under their management.
• Institutes performance metrics to evaluate the Office’s execution of its mission.
• Advises high-level Agency officials on administrative and regulatory programs and policies concerning Agency compliance responsibilities relating to the manufacture, distribution, importation, marketing, and promotion of tobacco products.
• Participates in and contributes to top level Center, Agency and Department discussions, meetings and conferences on broad compliance matters and issues.
• Monitors, coordinates, and advises the CTP Director on new or revised policies related to the Center’s compliance and enforcement responsibilities.
• Provides technical guidance and support in the development and review of standards, regulations, and guidance related to tobacco product compliance and enforcement, evaluates and monitors compliance and enforcement programs across the supply chain.
• Oversees the conduct of field tests and manufacturing inspections, and surveillance activities through among other things, product submissions, publication surveillance, and the internet.
• Evaluates regulated industry activities to ensure compliance with regulations relating to the Center’s overall compliance and enforcement efforts.
• Establishes and maintains effective relationships with top level FDA and government officials, industry representatives, program directors, senior scientific and academia officials, and state and local health and compliance officials.
• Represents OCE and CTP, including serving as spokesperson on matters under their areas of expertise, including through public presentations and attendance at conferences and other meetings.

Conditions of employment

• U.S. Citizenship is required for federal employment.
• Background and/or Security Investigation is required.
• Must complete 1 year SES probationary period, if not previously completed.
• Application package must be received by closing date of this Announcement.
• Ethics pre-clearance is required.

Qualifications

In order to qualify for Director, Office of Compliance and Enforcement ES-0696-00, you must possess the following:

• Specialized Experience Requirement
• Basic Qualification Requirements
• Education Requirement
• Technical Qualifications (TQs)
• Executive Core Qualifications (ECQs)

Specialized Experience Requirement
To be qualified for this position, your résumé must reflect experience in a managerial capacity with responsibility for providing supervisory direction to a large and diverse organization responsible for promoting economy, efficiency, and effectiveness in the administration of programs and operations and preventing and detecting fraud and abuse in such programs and operations. This experience must be evidenced by sophisticated analytical skills, superior written and oral communication skills, good judgment, and experience in interacting with government and non-government officials. Typically, experience of this nature is gained at or above the GS-15 grade level in the Federal service, or its equivalent with state or local government, the private sector, or nongovernmental organizations. At this level, you would have typically been responsible for planning, directing, and evaluating work that included managing and/or supervising other managers. You must demonstrate in your résumé, significant achievements, increasing levels of responsibility as a manager, and a solid record of successful professional performance.

Basic Qualifications Requirement As a basic requirement for entry into the Senior Executive Service (SES), your résumé must show evidence of progressively responsible leadership experience that is indicative of senior executive level management capability, and that is directly related to the skills and abilities outlined under the Technical Qualifications (TQs), and the five Executive Core Qualifications (ECQs) listed below. If you meet the qualifications for the Desirable Qualifications (DQs), please show in resume, however it is not required that you possess these qualifications.

1) Technical Qualifications (TQs); and
2) Executive Core Qualifications (ECQs)

Technical Qualifications (TQs) -- Your résumé must show that you possess the following TQs:
1. Experience which demonstrates strong leadership abilities in a scientific, regulatory or public health organization; demonstrated ability to develop program goals and strategic/tactical priorities; demonstrated ability to develop, direct and/or guide long-term and short-term projects and to conduct periodic program assessments.
2. Demonstrated ability to work effectively across organizational lines and beyond to build strong working relationships among people and organizations with diverse interests and/or opinions.
3. Knowledge and understanding of the provisions, limitations, and practical application of laws and regulations in a public health context.

Additional information on the proper preparation of ECQs is available by going to the Office of Personnel Management's web site at http://www.opm.gov/ses/references/GuidetoSESQuals_2010.pdf. Applicants are encouraged to follow the Challenge, Context, Action, and Result model outlined in the guide.

Executive Core Qualifications (ECQs) -- Your resume must show that you possess the following ECQs:
1.Leading Change
2. Leading People
3. Results Driven
4. Business Acumen
5. Building Coalitions

Fundamental Competencies are the foundation for success in each of the ECQs and should be evident over the course of your resume:

1. Interpersonal Skills
2. Oral Communication
3. Integrity/Honesty
4. Written Communication
5. Continual Learning; and
6. Public Service Motivation

It is STRONGLY recommended that you visit the following Office of Personnel Management (OPM) webpage for more information regarding the Fundamental Competencies and ECQs. https://www.opm.gov/policy-data-oversight/senior-executive-service/executive-core-qualifications/.

1. Leading Change: The ability to bring about strategic change, both within and outside the organization, to meet organizational goals. Inherent to this ECQ is the ability to establish an organizational vision and to implement it in a continuously changing environment. (Competencies: creativity and innovation, external awareness, flexibility, resilience, strategic thinking, vision)

2. Leading People: The ability to lead people toward meeting the organization's vision, mission, and goals. Inherent to this ECQ is the ability to provide an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork, and supports constructive resolution of conflicts. (Competencies: conflict management, leveraging diversity, developing others, team building)

3. Results Driven: The ability to meet organizational goals and customer expectations. Inherent to this ECQ is the ability to make decisions that produce high quality results by applying technical knowledge, analyzing problems, and calculating risks. (Competencies: accountability, customer service, decisiveness, entrepreneurship, problem solving, technical credibility)

4. Business Acumen: The ability to manage human, financial, and information resources strategically. (Competencies: financial management, human capital management, technology management)

5. Building Coalitions: The ability to build coalitions internally and with other Federal agencies, State and local governments, nonprofit and private sector organizations, foreign governments, or international organizations to achieve common goals. (Competencies: partnering, political savvy, influencing/negotiating)

The application process for this position is RESUME ONLY. You should address the TQs and ECQs within the context of a 5-page résumé. Any information submitted in excess of 5 pages WILL NOT be considered. We strongly encourage you to submit a résumé that is tailored specifically for this position to ensure it includes relevant examples of how you possess the technical qualifications and the five Executive Core Qualifications. Your résumé should emphasize your level of responsibilities, the scope and complexity of programs managed (e.g., budget, type/# of staff supervised) and program accomplishments, including the results of your actions.

If selected, you will be required to complete an ECQ package by drafting narratives for each of the ECQs for submission and certification by an OPM Qualifications Review Board (QRB) in order to be placed in this position. If you are currently serving in a career SES appointment, are eligible for reinstatement into the SES, or have successfully completed an SES Candidate Development Program approved by the Office of Personnel Management (OPM), you will not need to draft the ECQs.

Public Health Service Commissioned Corps Officers interested in applying for this position to serve in the SES must resign their commission if selected.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm ET on 11/30/2023).

Your résumé and responses to the Assessment Questionnaire are an integral part of the process for determining your basic and specialized qualifications for the position. Responses that are not supported by your résumé will eliminate you from consideration. Your application will be evaluated in the following manner:

1. Application packages will be reviewed for completeness. Incomplete or late packages will not receive further consideration.

2. Basic qualifications review. Your résumé and questionnaire will be reviewed to ensure that you meet the Specialized Experience Requirement. If you do not meet this requirement, you will not receive further consideration.

3. If it is determined that you meet the basic qualifications for the position, your application package will be further evaluated by a rating and ranking panel, and highly qualified candidates may be invited to participate in a structured interview, submit writing samples, and undergo reference checks. Top candidates may be required to submit further written documentation of qualifications.

4. The HHS FDA Executive Resources Board will review results and make recommendations on final selections to the appointing authority.

All information concerning qualifications is subject to investigation. You should expect that we will verify performance, suitability, security information and take that information into account in making employment offers. False representation may be grounds for non-consideration, non-selection, and/or appropriate disciplinary action. All initial appointments to an SES position are contingent on approval from OPM's Qualifications Review Board unless the selectee has successfully participated in an OPM approved SES Candidate Development Program. An individual's initial SES career appointment becomes final only after the individual successfully completes a 1-year probationary period. For additional information concerning the SES visit http://www.usajobs.gov/SeniorExecutives.