GLP Quality Systems Manager

Employer
USAJobs
Location
Fort Detrick, Maryland
Posted
Nov 21, 2021
Closes
Nov 28, 2021
Hours
Full Time
Duties

  • Systematic, critical, intensive investigation directed toward the development of new or fuller scientific knowledge of the subject studied.
  • Directing the identification, development, establishment, management and execution of a complex, medical research and development program to support missions such as biological defense, infectious disease, and environmental health surveillance.
  • Managing major changes to the structure and content of research programs.
  • Exercising discretionary authority to approve the allocation and distribution of funds from all sources (Army budgets as well as grants for scientific research) and executes studies, program reports, and other staff work independently.
  • Provides Good Laboratory Practices (GLP) guidance and strategic recommendations to Medical Countermeasures Test and Evaluation efforts throughout the Institute.
  • Technical advisor on GLP matters to the Institute's Test Facility Management and GLP study teams.
  • Assures the successful conduct of GLP-compliant test and evaluation studies for candidate medical products intended to provide medical countermeasures against biodefense agents.
  • Assessing and assuring the readiness and adequacy of GLP spaces, support services, processes and equipment prior to GLP study approval and initiation.


Requirements

Conditions of Employment

  • Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.
  • This position requires the incumbent be able to obtain and maintain a determination of eligibility for a Secret security clearance.
  • This position requires you to submit a Confidential Financial Disclosure Report (OGE 450) upon entry and annually thereafter.
  • Incumbent must sign DD Form 2888 (Critical Acquisition Position Service Agreement) and execute, as a condition of employment, a written tenure agreement. to remain in Federal service in the position for at least three years.
  • This is an Army Acquisition, Logistics, and Technology Workforce position. Selectees must meet the position requirements for certification at Level 3 in Science and Technology Manager within 24 months of entrance on duty.
  • This is a Critical Acquisition Position (CAP). Must be a member of an Acquisition Corps at the time of appointment or eligible for a waiver. Note: Waiver is position specific and must be approved prior to being appointed to the position.
  • Incumbents must maintain a current certification of enrollment in the Biological Personnel Reliability Program (BPRP) . Incumbent must submit to and satisfactorily complete suitability and reliability screening and analysis.
  • Incumbents must also be approved by the Department of Health and Human Services and the Department of Justice for access to laboratories containing biological select agents and toxins pursuant to the terms of 42 CFR Part 73
  • Pursuant to EO 14043, all Federal employees, regardless of duty location or work arrangement, must be fully vaccinated for COVID-19 by November 22, 2021, or before entrance on duty if after November 22, subject to exceptions as required by law.
  • If selected, the agency will provide information regarding what documentation is needed and how to request any legally required exceptions from the COVID-19 vaccine requirement.
  • Proof of vaccination will be required. To ensure compliance with this mandate, review the vaccination requirements, to include timelines for receiving required doses, at the following: https://www.saferfederalworkforce.gov/faq/vaccinations/
  • This position is subject to a pre-employment screening, and random testing thereafter, to include testing based on reasonable suspicion and testing due to direct involvement with an on-duty accident.


Qualifications

Who May Apply: US Citizens
The U.S. Army Medical Research and Development Command (USAMRDC) is a major subordinate command of the U.S. Army Futures Command. Our vision is to be a trusted partner for leading biomedical research and materiel innovation for global health. To achieve that vision, USAMRDC employs military, civilian, and contractor personnel that are assigned to the headquarters and subordinate units. The officers, enlisted service members, and civilian workforce provide a wide variety of medical, scientific, and technical expertise. Many of these personnel are among the most respected and knowledgeable specialists in their fields. USAMRDC's world-class reputation is the direct result of the outstanding leadership, work ethic, and selfless service of its highly talented workforce. Please visit our website https://mrdc.amedd.army.mil

USAMRDC is participating in an alternative personnel system known as the Personnel Demonstration Project (PDP). The DB-03 pay band is equivalent to the GS-13 step 1 to GS-14 step 10 level. In keeping with the Demonstration pay fixing policies, employees earning a salary that falls within this pay band equivalent, may not receive an immediate pay increase (promotion) if appointed to this position. Future pay increases within the pay band will be accomplished through the pay for performance management system.

In order to qualify, you must meet the education and experience requirements described below. 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). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document .

Basic Education Requirement: Degree: Bachelor's or graduate (or higher level) degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program accredited by an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.

In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below:

Specialized Experience: One year of specialized experience equivalent to at least the DB-02 (GS-12) grade level in the Federal service which includes: 1) Managing, directing, or coordinating the execution of funded research and development programs emphasizing the development of drugs, vaccines, devices, chemical defense, biological defense, and/or combat casualty care pharmaceutical products, to include technical content, regulatory matters, and/or cost, schedule and performance; (2) Developing and preparing system plans and programs, requirements for work and resources, analyzing functional requirements of program components, and developing program strategies for program components for pharmaceutical research AND (3) Coordinating review and approval for research protocols, coordinating budget, procurement and manpower requirements to support research and development operations. This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service DB-02 (GS-12).

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.

NOTE : Acquisition Corps (AAC) membership is required prior to appointment to a Critical Acquisition Position (CAP), except as noted in the paragraph below.

Acquisition Corp Members - Submit either your Acquisition Corps Membership Certificate; membership letter from the Agency's Director- Acquisition Career Management, Acquisition Career Record Brief (ACRB) or other agency equivalent document.

Non-Acquisition Corps Members - Submit your transcripts. Baccalaureate degree from an accredited educational institution and ONE of the following is required: 24 semester credit hours from among the following disciplines: accounting, business, finance, law, contracts, purchasing, economics, industrial management, marketing, quantitative methods, and organization and management. 24 semester credit hours in the person's career field and 12 semester credit hours in the disciplines listed above. Credit hours within the person's career field may also satisfy the requirement for part or all of the 12 credit hours in the disciplines listed above. The same hours may be used to meet both requirements. 24 semester credit hours in the person's career field and training equivalent (American Council on Education recommended credits) to 12 semester credit hours in the disciplines listed above.

Selectees must sign an AAC written tenure agreement to remain in the Federal service in this position for at least three years. Information on Army Acquisition, Logistics, and Technology Workforce and AAC membership may be found at https://asc.army.mil/ . Individuals with questions may contact an Acquisition Career Manager (ACM) for Assistance.

You will be evaluated on the basis of your level of competency in the following areas:
  • Investigation and Testing
  • Program Management
  • Research and Development


Education

***NOTE: TRANSCRIPTS ARE REQUIRED even if you are a current federal employee.***

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show 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; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html .

Only degrees from an accredited college or university recognized by the Department of Education are acceptable to meet positive education requirements or to substitute education for experience. For additional information, please go to the Office of Personnel Management (OPM) and U.S. Department of Education websites at - http://www.opm.gov/qualifications and http://www.ed.gov/admins/finaid/accred/index.html

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.

Additional information

  • Male applicants born after December 31, 1959, must complete a Pre-Employment Certification Statement for Selective Service Registration.
  • You will be required to provide proof of U.S. Citizenship.
  • Three year trial/probationary period may be required.
  • Direct Deposit of Pay is required.
  • This position requires you to submit a Public Financial Disclosure Report (OGE 278) or a Confidential Financial Disclosure Report (OGE450) upon entry, and annually thereafter.
  • Selection is subject to restrictions resulting from Department of Defense referral system for displaced employees.
  • If you have retired from federal service and you are interested in employment as a reemployed annuitant, see the information in the Reemployed Annuitant information sheet.
  • This is a Career Program (CP) 53 - Medical position.
  • You may claim military spouse preference.
  • If a MSP applicant is determined best qualified and selected, placement must be at the full performance level for priority consideration.
  • Multiple positions may be filled from this announcement.
  • Salary includes applicable locality pay or Local Market Supplement.
  • Interagency Career Transition Assistance Program (ICTAP). If you are a Federal employee in the competitive service and your agency has notified you in writing that you are a displaced employee eligible for ICTAP consideration, you may receive selection priority for this position. To receive selection priority, you must: (1) meet ICTAP eligibility criteria (2) be rated well-qualified for the position and; (3) submit the appropriate documentation to support your ICTAP eligibility. To be considered well-qualified and receive selection priority applicants must satisfy all qualification requirements for the position and receive a score of 90 or above. Additional information about the program is on OPM's Career Transition Resources website.
  • If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .
  • Payment of Permanent Change of Station (PCS) costs is not authorized.
  • You will be required to undergo a background investigation leading to the successful adjudication of eligibility for Secret security clearance. Derogatory information developed during the background investigation, such as a criminal history or an adverse credit history, could render the selectee ineligible for both the security clearance and continued employment in the position, if already appointed.
  • This is an Army Acquisition, Logistics & Technology Workforce position. Selectees must meet position requirements for certification at Level 3 in Acquisition Career Field Science & Technology Manager within 24 months of entrance on duty. (Certification requirements may be found in the Defense Acquisitions University Catalog at http://www.dau.mil/ )
  • This is a Critical Acquisition Position. Unless specifically waived by the appropriate Army official or if the employee is Grandfathered under 10 U.S.C. 1736(c) (1).
  • Selectee must be an Acquisition Corps member at the time of permanent selection for the position or have been granted a waiver.
  • Selectee must execute, as a condition of appointment, a written agreement to remain in Federal service in the position for at least 3 years. In signing such agreement, the employee does not forfeit any employment rights, nor does such an agreement alter any other terms or conditions of employment.


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