The Quality Unit within the CCE is responsible for ensuring the safety, quality, purity, potency, and effectiveness of all services and, activities in the CCE and for ensuring the reliability of services and data is in accordance with accrediting and regulatory agency requirements including NIH, USP, FDA and TJC.

Duties

As a Supervisory Quality Management Specialist (Cell Processing), GS-1910-13, your duties may include but are not limited to the following: Supervises a QA staff involved in implementing and administering the CCE QA Plan and managing regulatory affairs for the CCE. As a first-level supervisor, the incumbent: Plans work to be accomplished by subordinates, sets and adjusts short-term priorities, and prepares schedules for completion of work; Assigns work to subordinates based on priorities, selective consideration of the difficulty and requirements of assignments, and the capabilities of employees; Evaluates work performance of subordinates. Legally responsible to alert the Director, CCE if they determine that practices are out of control and pose a risk to patient or donor health or well-being, as required by federal law. Advises the Director, CCE in all regulatory and compliance matters and provides consultation for policies, procedures, and practices that will be in compliance with all federal regulations governing the manufacturing and distribution of cellular therapy products. Provides direction and consultation to the Assistant Directors, CCE (MD and PhD), and section Supervisory Medical Technologists/Biologists for the design, development, implementation, administration, supervision over and compliance with the QA/I and regulatory compliance as required by federal law. Manages the CCE QA program and performance of QA functions performed for the CCE (cell processing and gene therapy programs) to ensure compliance with GMP requirements for purity, potency, and safety of Cellular therapy products. In concert with CCE-QA/RA, coordinates regulated communications between the CCE and federal agencies including, but not limited to the FDA, CMS, and CDC; and accrediting agencies such as TJC and AABB. The incumbent serves as Records Manager and maintains cellular therapy establishment registrations, and regulated correspondence for all CCE activities. Supervises implementation, reviews, and ensures compliance with standard operating procedures (SOPs), policies, and instructions for all CCE QA activities, including the QA Plan, auditing, quality improvement and corrective action plans, and complaints; and delivers or coordinates initial and annual refresher cGMP/cGTP and Good Documentation Practices (GDP) training for all manufacturing staff.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• This position is a Tier 1 Emergency Essential position.
• A one-year supervisory trial/probationary period may be required upon selection/placement.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.

Qualifications

The incumbent serves as the Supervisory Quality Management Specialist (Cell Processing), responsible for quality assurance for one of the facilities in CCE, and directly supervises the Quality Assurance Specialists as well as the Clinical Laboratory Scientists (Quality). In order to qualify for a Supervisory Quality Management Specialist (Cell Processing), GS-1910 position at the GS-13 level, you must have: One year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: managing quality assurance activities for cell processing and/or gene therapy programs to ensure compliance with GMP requirements; ensuring compliance with cGMP regulations and Quality Assurance plans by providing interpretation, and guidance; leading or directing implementation of the goals of a Quality Assurance Program to maintain compliance with Federal and State laws and with accrediting agencies requirements; auditing, quality improvement and corrective action plans and complaints; and coordinating initial and annual refresher cGMP/cGTP and Good Documentation Practices (GDP) training for all manufacturing staff. Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application.? We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12433236

Education

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: NIH HR Service Desk Branch E
• Email: [email protected]