Program Manager Job in Silver Spring, MD

Vacancy No. FDA-OC-25-DE-12634866-CW Department Food and Drug Administration
Salary $163,964.00 to $191,900.00 Grade 15 to 15
Perm/Temp Permanent FT/PT Full-time
Open Date 12/10/2024 Close Date 12/19/2024
Job Link Apply Online Who may apply Public
Locations:
Silver Spring, MD


Summary

This position is located in the Office of the Commissioner (OC), Office of the Chief Scientist (OCS), Office of Occupational Safety and Health (OOSH) which coordinate and lead the Food and Drug Administration's (FDA's) Laboratory Quality Management System (LQMS) programs and operations central to that activity. The incumbent is responsible for managing and coordinating the implementation of LQMS initiatives on behalf of the Agency.

Duties

  • Serves as the recognized expert on matters involving the Agency’s laboratory accreditation efforts including ISO 17025, ISO 9001, ISO 17043, ISO 13485, and Good Laboratory Practices.
  • Manages and coordinates implementation of Laboratory Quality Management System (LQMS) initiatives on behalf of the Agency.
  • Provides oversight of Office of Laboratory Safety internal and external procedures that defines the program’s objective, scope, performance metrics, and requirements.
  • Collaborates and consults with scientists or program specialists to develop more viable implementation procedures and coordinates with staff to make those changes.
  • Serves as a technical information resource on quality management system issues and assists various work groups and tasks in the organization to identify novel approaches for use of quality management systems.
  • Provides guidance, interpretations and recommendations to senior Center officials, division directors, scientific and professional personnel, intra-governmental counterparts, and other concerning the Agency policies, programs and activities.

Requirements

Conditions of Employment

  • Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
  • Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
  • 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.
  • Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
  • Direct Deposit: 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.
  • A one year probationary and/or trial period for initial Federal employment may be required.
  • You must hold and maintain the required certifications. (see qualifications for details)

Qualifications

The position of Program Manager falls under the 0340 occupational series. To qualify for this position at grade GS-15, you must meet all requirements by 11:59 pm EST on 12/19/2024.

Selective Placement Factor:
Hold and maintain the following required certifications: ISO 9001:2015 Lead Auditor -OR- ISO 13485:2016 Lead Auditor -OR- ISO/IEC 17025 Lead Assessor; AND American Society for Quality (ASQ) Certified Quality Auditor (CQA) -OR- Certified Manager of Quality/Organizational Excellence (CMQ/OE).

**To meet selective placement factor you must provide proof of certification. **

AND

Minimum Qualifications:
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. The specialized experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations.

GS-15: You must have 1 year of specialized experience equivalent to at least the GS-14, in the Federal service, which includes: providing leadership in the design, implementation, and operation of programs, policies, and strategies tailored to meet laboratory quality management systems and program goals; serving as subject matter expert on laboratory accreditation, policy alternatives, monitoring and evaluating work products and their impact on program goals and resources.

NOTE: 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://secure.login.gov/, 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.

Education

There is no education substitution this position at the GS-15 grade level.

Additional information

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,
-OR-
(B) the pre-defined closing date of 12/19/2024, 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: 150

For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/

If you are serving or have served in the last 5 years (from 12/19/2024) 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. https://www.opm.gov/frequently-asked-questions/political-appointees-and-career-civil-service-positions-faq/
  • Incentives: 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.
  • Pre-Employment Physical: No
  • Drug Testing Requirement: No
  • License Requirement: No
  • Immunization Requirement: No
  • Mobility Agreement Required: No
  • Bargaining Unit: No
Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.

All requirements must be met by the closing date of this announcement (12/19/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

Benefits

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. Opens in a new windowLearn 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.

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 10% or higher must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
  • 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.
  1. Technical Competence
  2. Organizational Awareness
  3. Manages and Organizes Information
  4. Oral Communication
To preview the application assessment questions, click the link below:
https://apply.usastaffing.gov/ViewQuestionnaire/12634866

Required Documents

Resume: At a minimum, your resume should list the position title, employer name, 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 listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.


Transcripts and Professional Licensure: If the position has an education requirement or licensure requirement or you are qualifying based on education, unofficial transcripts or a list of courses and a copy of your professional license must be provided. See the Qualifications and Education Requirements section of this announcement.

I/CTAP:
If you are a current/former Federal employee who is surplus or displaced, please submit supporting documentation (e.g., a Certification of Expected Separation, separation notice, RIF separation notice, notice of proposed removal, SF-50 for RIF separation, etc.) and your most recent performance appraisal. To be selected under I/CTAP, you must be found well-qualified for this position and have a current performance appraisal rating of at least "Fully Successful". 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.

Veterans' Preference: Veterans must submit a DD-214 form (Certificate of Release or Discharge) that has the dates of service and discharge status and VA disability letter (if applicable).
  • Active Duty Members: To claim status under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011, 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 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.
  • 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.
Financial Disclosure: 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.
This position may require financial disclosure reporting and will 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. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

How to Apply

To apply for positions with the Food & Drug Administration, you must log intohttps://secure.login.gov/ account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 12/19/2024. We recommend that you start the application process early enough that you can complete and submit your application before this deadline.

Please note that you cannot submit documentation or make changes to your application after the deadline, and in most cases, only experience and education obtained by this date will be considered.

If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk is not able to support USAJOBS-related issues.

The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!

You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.

If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 866-807-3742, or e-mail ERIC@fda.hhs.gov. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 12634866 so that we may assist you faster.

Agency contact information

FDA Applicant Help Desk
Address
FDA Office of the Commissioner
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Learn more about this agency

Next steps

Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 12/19/2024), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities.

HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.

Once your application is submitted, you will receive an email notice confirming that your submission was successful. You will receive additional application status updates by email and through USAJOBS as the process unfolds.
How to check your application status and understand what each status means.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), professional references, or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Additional selections may be made agency-wide within the same geographic area.


Note: We cannot accept applications on behalf of Federal Agencies. Application instructions are listed within the Job Description.


© 2006-2024, exclusive of U. S. government job opportunity announcements