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

• 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.

Contacts

• Address FDA Office of the Commissioner 10903 New Hampshire Ave Silver Spring, MD 20993 US
• Name: FDA Applicant Help Desk
• Phone: 866-807-3742
• Email: [email protected]