QA Manager III
QA, Quality Control, Regulatory compliance and guidance, GCP
The NCI Center for Cancer Research (CCR) is the world’s leading catalyst for tomorrow’s cancer research and patient treatment. From the development of ground-breaking immunotherapy approaches to the creation of the human papilloma virus (HPV) vaccine, the CCR is working to solve the most pressing problems in the field through basic, translational and clinical cancer research to create the cancer medicines of tomorrow. Our mission to cure cancer touches every American in often personal ways.
Our scientists can’t do it alone. It takes a skilled, multi-disciplinary team of dedicated staff in research, patient care and administration to improve the lives of cancer patients and answer the most important questions in cancer biology and treatment. Be part of our mission to unlock the mysteries of cancer through research to create the medicines of tomorrow.
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
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
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
This position is located in Bethesda, Maryland.
Hiring for this position will be through Leidos Biomedical Research Inc., a wholly owned subsidiary of Leidos, Inc. Leidos Biomedical is the operations and technical support contractor for the Frederick National Laboratory for Cancer Research, a federal national laboratory.
To apply go to: https://leidosbiomed.csod.com/ats/careersite/JobDetails.aspx?site=4&id=115
HHS, NIH, and NCI are Equal Opportunity Employers