Quality Assurance Manager (NCI) (647900)

  • 02/19/2018

Job Description



The Leidos Biomedical Research, Inc. rsquo;s, staff of scientific, technical, and support professionals conduct basic and applied research in cancer and AIDS. It operates and manages the federal government rsquo;s only vaccine manufacturing facilities (Vaccine Pilot Plant [VPP] and Biopharmaceutical Development Program [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 Group rsquo;s Biospecimen Research Group (BRG) supports projects across the National Cancer Institute (NCI) that require expertise in the infrastructure needed to support the collection and use of human biospecimens for cancer research as well as other areas where scientific knowledge of advanced computing and/or scientific technologies is required.

The NCI rsquo;s Biorepositories and Biospecimen Research Branch (BBRB) and the Leidos Biomed BRG are jointly responsible for developing a common biorepository infrastructure that promotes resource sharing and team science, to facilitate multi-institutional, high-throughput genomic and proteomic studies. Currently, Leidos Biomed is supporting the NCI Cancer Moonshot℠ Biobank program. The NCI rsquo;s Cancer Moonshot℠ program is intended to accelerate cancer research in key strategic areas. The strategic areas were deliberated and identified by experts in the cancer research community convened in 2016 through a ldquo;Blue Ribbon Panel rdquo; (BRP). The BRP produced a set of recommendations that are now publicly available (https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel). The strategic areas addressed in the BRP recommendations have in common two core elements: (1) critical scientific and medical questions, the answers to which could rapidly accelerate progress in cancer research, and (2) the need for nationwide participation by a diverse group of research participants who have agreed to share their biospecimens and/or derived data to contribute to progress in cancer research. The latter element, an engaged and diverse research participant population and their donations of biospecimens and data, will be critical to accelerating research progress and is the subject of the project for which Leidos Biomed is seeking an experienced Quality Assurance Manager. The Cancer Moonshot℠ Biobank will provide a networked biospecimen resource that will serve the goal of the Cancer Moonshot℠ to accelerate research progress in cancer.

For the Moonshot℠ Biobank Program, up to 2,000 longitudinal cases from patients with 10 different cancer types will be collected, to include tissue resections, core biopsies, fine needle aspirates, and blood. The biospecimens will be utilized by researchers studying the mechanisms of drug resistance and sensitivity and other important cancer research questions. Subcontracts with up to 100 different cancer centers will be put in place to enable the engagement and participation of physicians and patients, including minority and underserved as well as adolescent and young adult cancer patients. Tumor molecular characterization tests will be performed as part of the program to help inform patient treatment decisions. Some tissues will be sent for Patient Derived Xenograft (PDX) model development at the Frederick National Laboratory for Cancer Research. A central Biospecimen Core Resource will be engaged for biospecimen processing and storage. Project data will be uploaded to the NCI Genomic Data Commons to enable data analysis by the broader research community.

The BRG also supports work being performed for the NCI rsquo;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.


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



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

  • Possession of a Bachelor #39;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 (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. 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 (e.g., 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 reg; inclusive of Word, Excel, Access and PowerPoint and principles of timelines within Microsoft reg; Project
  • Must be able to obtain and maintain a security clearance
  • Ability to travel approximately 10%


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
  • Knowledge of best practices in biobanking operations and biobanking data standards
  • Experience in biospecimen sciences research with knowledge of pre-analytical influence

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

Leidos Overview:
Leidos is a global science and technology solutions leader working to solve the world rsquo;s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company rsquo;s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin #39;s Information Systems amp; Global Solutions business (IS amp;GS). For more information, visit www.Leidos.com. The company rsquo;s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer. JBLeidos ICJBMeta