This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality, Office of Program and Regulatory Operations, Division of Operational Excellence, Learning & Professional Development (DOELPD) located in Silver Spring, Maryland. DOELPD assesses the quality of work products, processes, or services to ensure they are fit-for-their intended use and timely.
Provide occupational specific technical and administrative direction to subordinate employees.
Represent the Office Director in meetings and conferences with senior-level Agency and Department officials, industry representatives and Program Directors.
Oversee the development and approve the implementation of the Quality Management System and/or other established guidelines.
Serve as Division Director and technical expert and provide leadership, program direction and general oversight.
25% or less - You may be expected to travel up to 25 percent for this position.
Job family (Series)
1910 Quality Assurance
Conditions of Employment
You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
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.
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.
You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
The position of Supervisory Quality Assurance Specialist falls under the 1910 occupational series. To qualify for this position at grade GS-15, you must meet the following:
A. Undergraduate and Graduate Education:
Major study - quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields related to the position.
B. Specialized Experience:
Experience that demonstrated a practical knowledge in monitoring, controlling, or maintaining the quality of products or services in quality assurance, procurement, inspection, production, or related areas.
In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below:
Specialized Experience. Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.
You must possess 1 year of specialized experience equivalent to the GS-14 in the Federal service that includes experience providing direction and leadership to staff and general oversight of their duties; overseeing the development and implementation of quality management programs and systems within the pharmaceutical, biotechnology or other similarly regulated industries; managing quality control systems and quality assurance methods to determine risks and compliance standards associated with mitigating risk actions, AND monitoring and implementing process improvement functions for a quality assurance program.
Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone-no substitution of education for experience is permitted.
It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Be sure that any uploaded documents you provide in your application are free of document security or compression which might render the document unreadable by our system.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
You MUST submit a transcript which includes a list of courses, grades, completion dates, and quarter or semester hours earned by the closing date of the announcement. Unofficial transcripts will be accepted in the application package. Official transcripts will be required prior to appointment if selected.
If you are using education completed at 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. If you have transferred educational credit from a foreign institution to one in the U.S., you must still show that your foreign education was evaluated by an organization recognized by the Department of Education, even if that foreign education was accepted as transfer credit by a domestic college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
SUBMITTING YOUR TRANSCRIPTS:
Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. 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.
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.
See the Application Manager Documentation for tips on submitting your paper-based documents.
For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest in positions with the FDA, the agency reserves the option of setting an application number limit.
When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either:
(A) the day the limit is reached,
(B) the pre-defined closing date of 11/27/2020, whichever comes first.
If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET.
The application limit, if applicable, for this advertisement is: NO LIMIT
For more information about announcement closing, see:
ADDITIONAL CONDITIONS OF EMPLOYMENT:
If you are serving, or have served in the last 5 years (from 11/27/2020) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointee FAQ - OPM
Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
Special Appointing Authorities:
If you are applying for eligibility based on a disability, veteran status, or under a career transition program, please pay careful attention to the Required Documents section for a detailed explanation of eligibility requirements to include supporting documentation.
Please be advised that this position may 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.
Drug Testing Requirement:
Mobility Agreement Required:
Bargaining Unit Position:
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
About Category Rating (DEU) Procedures (Basis for Rating):
Category rating procedures will be used to rate and rank candidates.
The answers you provide to the applicant self-assessment questions will be used, in conjunction with the supporting documents you include, and your resume, to determine your eligibility for Federal employment and your qualification for this position specifically.
Your application score is used to place you into one of three quality categories: "Best Qualified", "Well Qualified", and "Qualified". (The category assignment is a measure of the degree in which your background matches the competencies required for this position.)
The cut-off score for each quality category may vary from announcement to announcement, and is determined by each agency, in advance of the advertisement going live.
Category Rating does not add veterans preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligible Vets who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30% must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
Only applications in the Best Qualified category are referred to the hiring office for consideration. If a high volume of applications are from highly qualified preference eligible Veterans, FDA's HR office may elect to refer ONLY those preference eligible Veterans. If FDA receives a small number of applications, or if the score range of applications in the highest quality category is low enough, the Best Qualified category may be merged with the Well Qualified category.
Interagency / Career Transition Assistance Program (I/CTAP):
Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the USAJOBS Career Transition Assistance Site.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not need to respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.
Manages and Organizes Information
Managing Human Resources
To preview the application assessment questions, click the link below:
Background checks and security clearance
Drug test required
Position sensitivity and risk
High Risk (HR)
Trust determination process
The federal government has very specific résumé requirements. If you have not written a federal résumé before, you may want to watch this Resume Writing Tutorial or the Resume Writing FAQ to see what details you should, and should not, include in your resume. A CV (curriculum vitae) may not contain enough information to meet these resume requirements. At a minimum, your resume should list the position title, employer name and address, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position included.
DD-214/ Statement of Service
Disability Letter (Schedule A)
Disability Letter (VA)
Other supporting documentation not listed
Separation Notice (RIF)
- Accepted documents may be required for some applicants, depending on which eligibility options you are applying under. See the list below for details.If you are still unsure what documents might be required of you, contact the FDA Applicant Help Desk before the announcement closes. If you need help attaching documents to your application, see Applicant Help Site - Documents.
For details about transcript requirements, see the Education section.
Veterans or Military Spouses:
Must submit a copy of your DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status.
Active Duty Members:
To claim status under the VOW (Veterans Opportunity to Work) to hire Heroes Act of 2011, you must submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
Parents of Deceased or Disabled Veterans:
To claim status under Gold Star Fathers Act of 2015, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
Widow or Widower:
To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
Spouse of a Living Veteran:
To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.
See Feds Hire Vets or USAJOBS' Veterans page for more information.
Other Special Eligibility Documentation Requirements:
Individuals with Disabilities:
Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. You can learn more about this appointment type on the USAJOBS Help Center page for Individuals with Disabilities.
If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site.
If you are relying on your education to meet qualification requirements:
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.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Learn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered.
This job is open to
Career transition (CTAP, ICTAP, RPL)
Federal employees who meet the definition of a "surplus" or "displaced" employee.
U.S. citizens, nationals or those who owe allegiance to the U.S.