Quality Assurance Manager (NCI)

Leidos Biomedical Research, Inc.
Frederick, MD
Oct 12, 2017
Oct 16, 2017
Full Time
PROGRAM DESCRIPTION The Leidos Biomedical Research, Inc.'s staff of scientific, technical, and support professionals conducts basic and applied research in cancer and AIDS. It operates and manages the federal government's only vaccine manufacturing facilities (VPP, BDP), and runs the high-performance Advanced Biomedical Computing Center. It also operates the Frederick National Laboratory for Cancer Research, a Federally Funded Research and Development Center focused on cancer and AIDS research. The Leidos Biomedical Research Biospecimen Research Group (BRG) supports The National Cancer Institute's (NCI) Biorepositories and Biospecimen Research Branch (BBRB) and is jointly responsible for developing a common biorepository infrastructure that promotes resource sharing and team science, in order to facilitate multi-institutional, high throughput genomic and proteomic studies. The BRG supports a new Biobank project funded through the National Cancer Institute Cancer MoonshotSM Program. The Biobank project will serve the scientific needs of research projects funded by NCI. The biobank will acquire and perform quality control and distribution of clinically-annotated pre- and post-treatment tumor and blood biospecimens from a broad range of adult and young adult patients, including longitudinal samples. The BRG also supports work being performed for the NCI's Center for Strategic Scientific Initiatives (CSSI), specifically the Clinical Proteomic Tumor Analysis Consortium (CPTAC), a comprehensive and coordinated effort to accelerate the understanding of the molecular basis of cancer with the primary goal to improve the ability to diagnose, treat and prevent cancer by systematically identifying proteins that derive from alterations in cancer genomes and related biological processes, and provide this data with accompanying assays and protocols to the public. KEY ROLES/RESPONSIBILITIES This position description does not represent a current opening but may be used to identify candidates with skills and experience for positions within Leidos Biomedical Research that frequently become available. Candidates who express an interest may be considered for future positions at Leidos Biomedical Research. The Quality Manager II will: Support the Director of Quality by managing Quality schedules and resources, and establishing/improving QA/QC systems Conduct quality reviews/audits, tracking, and metrics analysis Review/approve Standard Operating Procedures (SOPs) and protocols Play an integral role in a multidisciplinary project team effort leading the discovery of proteomic and genomic signatures of cancer Provide quality expertise Draft and review audits, QC plans and other quality related reports Manage development and analysis of quality metrics pertinent to product and service quality Manage quality systems including: change control/deviation reporting, training and document control Represent the Quality department at project team meetings and during interactions with clients/subcontractors Conduct scientific evaluation of technical data to ensure product quality objectives are consistently met Report on quality team status and metrics Supervise subordinate staff Travel both domestic and international approximately 10% of the time BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a Bachelor's degree from an accredited college or 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 US equivalency Six (6) years of experience in relevant experience in quality assurance for life sciences, including two (2) years of experience in a leadership capacity. Knowledge of quality assurance concepts and practices and managing basic quality systems (eg, change control, deviation reporting, training and document control, metrics analysis) Knowledge of Quality Control for molecular analysis in support of genomics and/or proteomics research Knowledge of Food and Drug Administration (FDA) regulations, including Good Clinical Practice (GCPs) Ability to independently conduct audits and quality reviews to drive evaluation and improvement in logistical and operational protocols Proficiency in Microsoft Office(R) inclusive of Word, Excel, Access and PowerPoint and principles of timelines within Microsoft(R) Project Must be able to obtain and maintain a security clearance Ability to travel approximately 10% PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Ability to conduct risk assessments, oversee investigations and lead audits Expertise in a variety of disciplines tangential to the science An understanding of the technical and programmatic areas of biobanking human specimens EXPECTED COMPETENCIES Ability to communicate effectively, verbally and in writing, with non-technical and technical staff at various levels of the organization Ability to prioritize multiple tasks/projects Ability to function independently and/or collaboratively within a team setting Ability to effectively manage, train and mentor subordinate staff

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