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This Position Is No Longer Available

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-AD-13-826632

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

The contents of the announcement can still be viewed.
$123,753.00 to $199,700.00 / Per Year
Friday, January 25, 2013 to Monday, February 25, 2013
Full Time - Excepted Service Permanent
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 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 reports to the Associate Commissioner for Regulatory Affairs (ACRA), Office of Regulatory Affairs (ORA), Office of Global Regulatory Operations and Policy (OGROP), within the Food and Drug Administration (FDA) in Rockville, Maryland. The Office of Regulatory Affairs (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.

Executive level compensation package is commensurate with qualifications and experience, which may result in a higher salary than reflected above.

Applications will be accepted from all groups of qualified persons, including non-citizens and Public Health Service Commissioned Officers.  No previous federal experience is required.  This is an Excepted Service position under Title 42.  This appointment does not confer any entitlement to a position in the competitive service and no entitlement to Merit Systems Protection Board (MSPB) appeal rights.




  • Background and/or Security Investigation required.


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The incumbent serves as the Assistant Commissioner for Operations in the Office of Operations (OO) for the Office of Regulatory Affairs (ORA) in the Office of Global Regulatory Operations and Policy (OGROP).  As the Assistant Commissioner for Operations, the incumbent will evaluate the scientific needs of regulatory operations and enforcement actions in order to assess/allocate/assign ORA's nationwide scientific field laboratory resources, scientific personnel, and other resources to ensure consistency of FDA regulatory actions.

The incumbent manages and directs FDA's nationwide network of field operations consisting of investigational, compliance/enforcement, analytical and administrative components, using a strategic problem-solving approach towards compliance and enforcement that focuses on impacts and results.

Coordinates compliance and enforcement efforts across the FDA Centers, i.e., finds ways to assure that individual Center plans are brought into a comprehensive approach.  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 information, administrative, civil, and criminal compliance and enforcement measures.

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.  The incumbent will provide knowledge/input 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.

As the Assistant Commissioner for Operations, the incumbent will represent 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.

Participates with the ACRA and Deputy Associate Commissioner for Regulatory Affairs (DACRA) in managing ORA's geographically dispersed workforce and laboratories strategically located throughout the U.S.; directing the nationwide regulatory workforce in enforcing compliance with the Federal Food, Drug, and Cosmetic Act and multiple other federal laws and regulations that apply to regulated products.

Serves as the 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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Basic Qualifications for AD-0696 (Consumer Safety Officer):  Applicants must possess a degree: that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming OR combination of education and experience -- courses consisting of at least 30 semester hours in the fields of study described above, plus appropriate experience or additional education.

In addition, applicants must possess a Ph. D. or other earned doctorate in a field related to the position to be filled.

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 that demonstrates the ability to manage a scientific and regulatory program.

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

3.   Managerial experience at the senior level which demonstrates strong leadership abilities in planning, implementing, executing and evaluating, multidisciplinary activities of significant scope and effect.

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.

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 evaluation 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:

Candidates much show clear evidence of specialized experience.  Specialized experience is that which is directly related to the position and which has equipped the applicant with the particular knowledge, skills, and abilities (KSAs) to successfully perform the duties of the position to include senior level experience in consumer safety.







Applicants must meet the qualification requirements as outlined above to be eligible for further consideration.  Your must provide detailed evidence of the experience, knowledge, skill, ability, and other personal characteristic requirements and show how and when they were used.  This evidence must include clear, concise examples that show level of accomplishment and degree of responsibility.  Qualification determinations will be based on the information provided in your application and the requirements of the position.  Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics).


Conditions of Employment:

1. Security and Background Requirements:  If not previously completed, a background security investigation will be required for all appointees.  Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication.  Failure to successfully meet these requirements may be grounds for appropriate personnel action.  In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time.  Applicants are also advised that all information concerning qualifications is subject to investigation.  False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.

2. E-Verify:  If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.  Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system.  The U.S. Department of Health and Human Services is an E-Verify Participant.

3. Direct Deposit:  All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.

4. All qualification requirements must be met by the closing date of the announcement.

5. Financial disclosure statement may be required.

6. One-year probationary period may be required.

7. Travel, transportation, and relocation expenses may be paid.

8. Bargaining Unit Position: No

9. Drug Screening Required: Yes

10. Recruitment or Relocation Incentive may be authorized: May Be Authorized.


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


Other Information

Males born after December 31, 1959 must be registered or exempt from Selective Service (see

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:  826632.  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.  Your Resume

2.  Completion of online Questionnaire; 

3.  Other supporting documents:

     -   College Transcripts, foreign education evaluation, SF-50 (if prior federal service)

Note:  You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received.  An official transcript from an accredited educational institution is required if you are selected for the position.

The complete Application Package must be submitted by 11:59 PM (EST) on the closing date.


Glenda D. Miller
Phone: (301)492-4653
Agency Information:
HHS FDA Center Executive Resources
10903 New Hampshire Avenue
Silver Spring, MD


Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful.  When the vacancy announcement closes, an evaluation of your qualifications will be determined by a panel of experts.  The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview.

Once this process is completed (generally 4-6 weeks), you will receive notice via email.  If no email address was provided by you during the application process, notice will come via US mail.

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