This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:Assistant Commissioner for Operations, Office of Regulatory Affairs

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-ES-2013-826307

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.


$119,554.00 to $179,700.00 / Per Year


Friday, January 25, 2013 to Monday, February 25, 2013




Full Time - Senior Executive Service (SES)


1 vacancy in the following location:
Rockville, MD United StatesView Map


All groups of qualified individuals


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

This position is in the Senior Executive Service (SES), a small elite group of senior government leaders who possess a diverse portfolio of experience and the strong skills required to lead across organizations.  This dedicated corps of executives is charged with providing strategic leadership and upholding a commitment to public service that transcends loyalty to a specific agency mission or individual profession.  As an SES member you will influence the direction of innovation and transformation of the federal government and lead the next generation of public servants.  This position reports to the Associate Commissioner for Regulatory Affairs (ACRA), Office of Regulatory Affairs (ORA), Global Regulatory Operations and Policy, within the Food and Drug Administration (FDA).  ORA is the lead office for all field activities at the FDA.  Regulating more than 135, 000 business establishments that annually produce, warehouse, import and transport $1 trillion worth of consumer goods, ORA protects consumers by maximizing compliance of FDA regulated products and minimizing risk associated with these products.  More than 4,000 ORA personnel in more than 200 locations work every day to minimize public health risk.

Position may be also filled under the Title 42 (T42 salary may be set at a higher rate commensurate with the individual's experience).

Title 42 position is also advertised under Job Announcement Number HHS-FDA-AD-13-826632.


  • U.S. Citizenship is required.
  • Background and/or Security Investigation required.
  • Must complete 1 year SES probationary period, if not previously completed.
  • Application package must be received by closing date of the announcement.


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The incumbent fully participates with the Associate Commissioner for Regulatory Affairs (ACRA) and the Deputy Associate Commissioner for Regulatory Affairs (DACRA) in providing leadership and managerial direction, through subordinate managers, to ORA's Office of Enforcement and Import Operations, Office of Food and Feed Operations, Office of Medical Products and Tobacco Operations, Office of Regulatory Science, and the nationwide field force comprised of Regions, Districts, Residents Posts, multiple state-of-the-art scientific laboratories and over 3600 employees engaged in ensuring compliance with FDA laws/rules/regulations for all domestic and imported FDA regulated products.

Leadership for Operations

Manages and directs FDA's nationwide network of field operations consisting of investigational, compliance/enforcement, analytical and administrative components.  Uses strategic problem-solving approach towards compliance and enforcement that focuses on impacts and results.  Uses systematic identification of important problems, risk assessment and prioritization, and effective collaborations with multiple interested parties. Coordinates compliance and enforcement efforts across the Centers, i.e., finds ways to assure that individual Center plans are brought into a comprehensive approach.  Assures consistency of approach across Regions and Districts of ORA.  Develops means of assuring consistency in training and credentialing investigators.  Develops programs to assure consistency of product safety and efficacy between domestic and imported products.  Undertakes strategic and risk-based global industry oversight and enforcement using a variety of tools, including inspections, sound regulatory science and policy, risk-based analytics, modern information technology, partnerships with state, Federal and global entities, and informal, administrative, civil, and criminal compliance and enforcement measures.  Provides leadership and guidance for the HSP/Bio-Reasearch Monitoring Program initiative by directing and overseeing ORA's participations in the scientific review of the Bio-Research Monitoring Program which includes all FDA Centers and ORA to evaluate its scope and scientific relevance to current needs.


Serves as the primary strategist and provides executive leadership for developing programs to achieve compliance with FDA's laws and regulations.  Advises and assists in developing international policies to assure compliance by regulatory industries that provide for the protection of the nation's public health.  Provides leadership, knowledge, and expertise into the development of risk-based nationwide inspection, compliance programs and enforcement strategies to achieve work efficiencies by focusing allocated resources and targeting the safety and security of food and drug supplies.

Public Health/Scientific

Assures that the latest scientific tools and techniques are applied in ORA laboratories and in all FDA compliance and enforcement actions.  Obtains scientific advice and external peer review to assure that the highest quality science is applied to the protection of the nation's public health.  Develops innovative programs for alternative means of obtaining regulatory compliance and protection of the nation's public health that emphasize problem solving, risk assessment, prioritizing results, collaboration and leveraging FDA resources.  Represents FDA regulatory programs to the general public and FDA's specific regulatory constituencies, which includes compliance/enforcement/operational activities such as seizures, civil money penalties, and injunctions; conducting foreign and domestic pre-market and post-market inspections of foods, human drugs, biologics, animal drugs and feeds, tobacco products and medical services.  Participates with the ACRA and DACRA in managing ORA's geographically dispersed workforce in enforcing compliance with the Federal Food, Drug, and Cosmetic Act and multiple other federal laws and regulations that apply to regulated products.  Provides knowledge to analyze and determine a proportional response to the level of significance of the threat.  This also includes the incumbent's activation/coordination of ORA and other Federal, State and local resources needed to assure prompt action and follow up to secure the nation's supply of food, drugs and life-saving medical necessities during a crisis.  Principal ORA coordinator, focal point and conduit for responding to terrorist threats and events which includes analysis to determine the proportional response to the level of significance of the threat.  The incumbent may need to activate/coordinate ORA and other Federal, State and local resources needed to assure prompt action and follow up to secure the nation's supply of food, drugs and life-saving medical necessities during a crisis, such as the Food Emergency Response Network (FERN), a joint Federal-State network of scientific laboratories/analytical resources.


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Specialized Experience Requirement To be qualified for this position, you must provide evidence of experience in a managerial capacity. 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.

Senior Executive Service Requirements

Current or former career SES employees are not required to address the Executive Core Qualifications (ECQs), but must address the Mandatory Technical Qualifications.  Unless you are currently serving under a career SES appointment, are eligible for reinstatement into the SES, or have successfully completed a SES Candidate Development Program approved by OPM, you must submit a narrative statement covering each of the Executive Core Qualifications in order to receive consideration for the position.

Public Health Service Commissioned Corps Officers interested in applying for this position to serve in the SES must resign their commission if selected.  If you are applying under this option, you must address both the Mandatory Technical Qualifications and Executive Core Qualifications in this announcement.  Public Health Service Commissioned Corps Officers interested in performing the duties of the position within the Commissioned Corps must address the Mandatory Technical Qualifications but are not required to address the Executive Core Qualifications.

Additional information on the proper preparation of ECQs is available by going to the Office of Personnel Management's web site at  Applicants are encouraged to follow the Challenge, Context, Action, and Result model outlined in the guide.

When responding to the Executive Core Qualifications, you must clearly show that you possess the experience, knowledge, skills and ability to perform the duties of this position by submitting narrative responses in which you detail your experience in each Executive Core Qualification.

Your examples should be clear and emphasize your level of responsibilities, scope and complexity of programs managed, program accomplishments with results of your actions, policy initiatives and level of contacts.  In addition, your responses should highlight your experience, training, and achievements in conjunction with the resume that you provide.  You should limit your narrative to two pages per each ECQ.

Mandatory Technical Qualifications

In addition to specialized experience, applicants must possess the following technical qualifications that represent the knowledge, skills, and abilities essential to perform the duties and responsibilities of the position:

1.  Senior level experience as a leader in a complex organization managing, planning, directing, and evaluating multidisciplinary activities of significant scope and effect.

2.  Demonstrated ability to build strong working relationships among people and organizations with diverse interests and/or opinions, such as industry, professional, public health or consumer organizations, media, other federal, state, or local agencies, foreign governments and Congress.  

3.  Experience advising senior officials and implementing organizational policy.

Desirable Qualifications

It is desired that you have:

1.  Training, professional development, and outside professional activities that provide evidence of initiative, resourcefulness and potential for effective job performance at a senior level, and honors, awards, or other recognition for performance or contributions related to the position.

2.  An advanced degree such as Juris Doctorate, Doctor of Philosophy, Medical Doctor, Masters in Business Administration or a Masters in Public Health degree. 

Executive Core Qualifications (ECQ)

Fundamental Competencies:  The following competencies are the foundation for success in each of the ECQs.  Interpersonal Skills; Oral Communication; Integrity/Honesty; Written Communication; Continual Learning; and Public Service Motivation.  These Fundamental Competencies are cross-cutting and should be addressed over the course of your ECQ narratives.

1.  Leading Change:  This core qualification involves 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:  This core qualification involves 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:  This core qualification involves 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:  This core qualification involves the ability to manage human, financial, and information resources strategically.  (Competencies:  financial management, human capital management, technology management)

5.  Building Coalitions:  This core qualification involves 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)

Other Requirements

The Ethics in Government Act, PL 95-521 requires the applicant selected for this position to submit a financial disclosure statement, SF-278, prior to assuming the SES position, annually, and upon termination of employment.  Status applicants must submit a copy of their most recent SF-50, Notification of Personnel Action, which verifies status.

All applicants will be considered without regard to race, color, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, disabling condition, membership in an employee organization, or any other non-merit factors.

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.

In accordance with Federal and Agency Travel regulations, the payment of travel and relocation expenses may be reimbursed for travel, transportation and relocation expenses associated with reporting for duty to this position.

As a condition of employment, all male applicants born after December 31, 1959, must have registered for the selective service.  If selected for this position, the applicant must sign a statement certifying his registration, or the applicant must demonstrate exempt status under the Selective Service Law.

Only experience obtained by the closing date of this announcement will be considered.


Your resume and narrative responses to the technical qualifications and the five Executive Core Qualifications are an integral part of the process for determining your basic and specialized qualifications for the position.  Responses that are not supported by your resume 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 resume 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.  Review of your supplemental qualifications document to determine your rating.


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The Federal Government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at


Veteran's Preference does not apply to the SES.

Drug Free Workplace

The incumbent of this position will be subject to testing for drug usage in accordance with the HHS plan for a Drug Free Workplace.

This position within FDA is subject to strict restrictions on financial holdings (FDA regulated financial holdings).  Applicants are advised to seek additional information from the Ethics Staff prior to accepting such a position.  Please refer to the following website.



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To apply for this position, you must provide a complete Application Package, which includes ALL of the documents listed in the Required Documents section of this vacancy announcement.  Any documents submitted that are not listed in the Required Documents section of this announcement will not be considered or forwarded to the rating panel or selecting official.

Application packages for this vacancy must be received on-line via the USA Staffing web site by 11:59 PM (EST) on Monday, February 25, 2013.

To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account.  Follow the prompts to complete the assessment questionnaire.  You may preview the assessment questionnaire by clicking here:  View Occupational Questionnaire.  Please ensure you click the Submit My Answers button at the end of the process. 
Note:  To return to a previously Saved or Incomplete application you may use the following link:

To fax supporting documents you are unable to upload, complete this cover page using the following Vacancy Identification Number:  826307.  Fax your documents to 1-478-757-3144.

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful.

If applying online poses a hardship to you, please contact the Human Resources Operations Center HelpDesk Telephone (888)478-4340, TTY/TTD (800)877-8339; or email  You must contact the Human Resources Operations Center HelpDesk prior to the closing date of this announcement to receive assistance.  The decision on granting reasonable accommodation will be made on a case-by-case basis.  Hours of operation:  Monday through Friday 7:30AM to 4:00PM EST.


1. Resume - Ensure that your resume contains your full name, address, phone number, and social security number.  When uploading your resume, choose the supporting document type called "Resume;"

2. Completion of online Questionnaire; including responses to Mandatory Technical Qualifications (MTQs) and Executive Core Qualifications (ECQs); 

3. SF-50, Notification of Personnel Action, showing your current or former civil service status, if applicable.

4.  Proof of OPM Qualifications Review Board certification (OPM-approved SES Candidate Development Program graduates), if applicable.

If you do not submit the documents above by the closing date of the announcement, the system will consider your application incomplete, and you will receive no further consideration.  Any documents submitted that are not listed above will not be considered or forwarded to the rating panel or selecting official.


Keya D. Duke
Phone: (240)402-4355
Agency Information:
HHS FDA Center Executive Resources
10903 New Hampshire Avenue
Silver Spring, MD


We expect to make a selection within 90 days of the closing date of this announcement.  You will be notified of the outcome by e-mail using the e-mail address on file in the Application Manager system, or by postal mail if no email address was provided by you during the application process.

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