Quality Assurance Manager II

Job ID: req2575
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION
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 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 (NIH) 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 monitoring, 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 Directorate (CRD) provides support of Quality Assurance and regulatory compliance activities pertaining to the manufacture of retroviral vectors and cell therapies under cGMP and GTP requirements applicable to Phase I/II clinical trials as outlined primarily in 21 CFR 210.1, 211.113, 610.12, 1271, and FDA Guidance for Industry documents.

KEY ROLES/RESPONSIBILITIES

• Assists in providing regulatory guidance and QA/compliance support for manufacturing of, and clinical research with, investigational drugs, biologics, or devices for use in clinical studies (i.e., manufacturing, and clinical research)
• Attends meetings with other staff to represent NCI Surgery Branch (SB) in developing strategies for engaging and responding to concerns of these authorities
• Reviews documents for completeness; and provides essential information for specialists and researchers; track and monitor assigned projects
• Assists with audits from regulatory agencies and performs internal audits and vendor audits
• Assists with the creation, implementation, and follow up of Corrective and Preventive Actions (CAPA)
• Assists with the documentation, investigation, and follow up of deviations/non-conformances
• Works with operations staff (quality control, manufacturing) to plan, qualify, verify, and validate new testing or manufacturing processes and equipment (change control)
• Reviews batch records and test results for completeness, accuracy, and compliance with specifications prior to release of product
• Utilizes scientific knowledge to prepare guidance documents and other documents to support clinical manufacturing activities within the NCI SB
• Assists with designing training programs for cGMP and FDA-regulated phase I/II manufacturing and manufacturing support areas
• Provides the initial review of inquiries from audits, research support staff, and research sponsors, analyzes quality assurance issues related to manufacturing, quality control and regulatory affairs, and uses knowledge, gleaned from research of appropriate internal and external requirements and databases to develop appropriate risk management strategies
• Liaison and handles inquiries related to clinical manufacturing activities to develop tailored and general guidance to ensure regulatory compliance
• Advises on the impact of changes in mission or resources and recommends alternative courses of action and possible solutions for resolving management problems in areas such as systems, manpower utilization, productivity management, workflow, and paperwork management
• Analyzes and prepares program status reports for review; recommendations for effective organizational changes to promote efficiency and compliance
• Prepares standard operating procedures for quality control, manufacturing, and quality assurance processes
• Participates in the review and revision of standard operating procedures to adhere to FDA regulations, GMP, and NCI SB QMS
• Reviews documents for content, accuracy, and compliance with applicable regulations prior to submission to regulatory agencies and approval for staff training
• Ensures compliance with regulatory requirements (cGMPs) by evaluating regulatory systems, policies and procedures, training programs and staff
• Develops various statistical tables and reports, new or modified work methods, management processes and procedures for administering program services, guidelines and procedures for program operations, and the effectiveness of programs in meeting established goals and objectives
• Future supervision of lower-level staff
• This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of bachelor'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 four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to education requirement, a minimum of six (6) years of progressively responsible quality assurance experience and four (4) additional years of experience in a leadership capacity
• Experience with reviewing manufacturing documents for the release of cGMP products
• 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 appropriately handle competing priorities
• Proficiency in Microsoft Office® inclusive of Outlook, Word, Excel, and PowerPoint
• Ability to effectively manage, train and mentor subordinate staff
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience with cell and/or vector therapy manufacturing

JOB HARZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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