Quality Assurance Manager III (NCI) - Bethesda, MD | Biospace
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Quality Assurance Manager III (NCI)

Leidos Biomedical Research, Inc.

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Location:
Bethesda, MD
Posted Date:
6/9/2017
Position Type:
Full time
Job Code:
637940
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

PROGRAM DESCRIPTION
Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

JOB DESCRIPTION/BASIC FUNCTION
The Clinical Monitoring Research Program (CMRP) provides quality assurance and regulatory compliance support to the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch Cell Production Facility, Department of Transfusion Medicine, Quality Assurance and Regulatory Affairs Office (DTM-QA).

The Quality Assurance Manager III (QA Mgr. III):
Supports quality assurance and regulatory compliance activities pertaining to the manufacture of cell therapies under cGMP (Current Good Manufacturing Practices) and GTP (Good Tissue Practices) requirements applicable to Phase I/II clinical trials as outlined primarily in 21 CFR 210.1, 211.113, 610.12, 1271, and FDA (Food and Drug Administration) Guidance for Industry documents
Participates in the review and revision of standard operating procedures to adhere to FDA regulations and GCP (Good Clinical Practices) guidelines
Ensures compliance with regulatory agencies by evaluating regulatory systems, policies and procedures, training programs and staff
Reviews documents for content, accuracy and compliance with applicable regulations prior to submission to regulatory agencies
Prepares standard operating procedures for quality control and monitors quality assurance standards

Requirements

BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
Possession of Master’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/scientific discipline (Additional qualifying experience may be substituted for the required education)
PhD preferred
Foreign degrees must be evaluated for U.S. equivalency
A minimum of eight (8) years of progressively responsible job related experience including three (3) years of experience in a leadership capacity
Must be detail-oriented and possess strong organizational, analytical and problem solving skills with the ability to prioritize multiple tasks/projects
Ability to perform job requirements independently and in team environments and must have ability to interface with all levels of management
Strong communication skills, analytical ability and solid interpersonal skills
Ability to work in a high-pressure, time-sensitive situation
Ability to multi-task and appropriately handle competing priorities
Must be able to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint
Principles of timelines within Microsoft® Project
Familiarity with interactive databases, quality assurance, quality systems, auditing, metrics analysis, cancer