QA Manager III, Cell Therapy Manufacturing

Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD), various clinical support teams provide 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), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD'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, CRD 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. CRD'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.

The Clinical Research Program Directorate (CRD) 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).

KEY ROLES/RESPONSIBILITIES

• 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 (SOPs) 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 SOPs for quality control and monitors quality assurance standards

This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

• 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 or six (6) years relevant experience in lieu of degree
• Foreign degrees must be evaluated for U.S. equivalency
• A minimum of eight (8) years of progressively responsible quality assurance experience including three (3) years of experience in a leadership capacity
• Experience with reviewing manufacturing documents for the release of blood or tissue products for infusion
• Knowledge of cGMP, GTP, GCP and FDA regulations and guidelines
• Experience ensuring compliance with regulatory agencies and reviewing and revising SOPs
• Ability to independently conduct audits and quality reviews to drive evaluation and improvement in logistical and operational protocols
• 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 independently and in team environments and must have ability to interface with all levels of management
• Ability to communicate effectively verbally and in writing
• Ability to work in high-pressure, time-sensitive situations; ability to multi-task and appropriately handle competing priorities
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• PhD
• Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint and principles of timelines within Microsoft® Project
• Familiarity with interactive databases, quality systems, auditing, metrics analysis, cancer