Job: Director of Quality Management (SAIC; Frederick MD)
Director of Quality Management
SAIC-Frederick, Inc.
Location:
Frederick, MD
Posted Date:
Jun 28, 2010
Position Type:
Full Time
Job Code:
1879034HHL
Required Education:
Masters Degree
Areas of Expertise Desired:
Description
SAIC is a FORTUNE 500; scientific, engineering, and technology applications company that uses its deep domain knowledge to solve problems of vital importance to the nation and the world, in national security, energy and the environment, critical infrastructure, and health. The company’s approximately 45,000 employees serve customers in the U.S. Department of Defense, the intelligence community, the U.S. Department of Homeland Security, other U.S. Government civil agencies and selected commercial markets. Headquartered in McLean, Va., SAIC had annual revenues of $10.8 billion for its fiscal year ended January 31, 2010. SAIC: From Science to Solutions;
The Clinical Services Program’s primary mission is to perform sequential studies of immune function in patients with cancer, AIDS, chronic granulomatous disease or other diseases associated with immunologic dysfunction. Integral to this work is the NCI’s Office of Biorepository and Biospecimen Research (OBBR) efforts through the Biospecimen Research Network (BRN) to establish Best Practices in proper biospecimen collection, processing, storage and shipping of all biological materials (tissue, blood, urine, etc.) involved in basic and clinical cancer research. These efforts are necessary to establish the Cancer Human Biobank (caHUB), which will be a unique, non-profit, public resource whose primary mission is to ensure the adequate and continuous supply of human biospecimens of measurable quality to the biomedical research community. IcaHUB will first be developed as a pilot endeavor, which will last at least 2 years and then it will transition into a permanent operation. The Director of Quality Management will assist in determining if the Offerors’ described TQM system is appropriate and sufficient to yield high quality specimens and scientific data. Will participate in site visits and audits at TSSs (may travel 30 – 40% of the time) to confirm the existence and continued functionality of a TQM system, respectively. Possible integration and/or blending of several distinct TQM systems at various subcontractors, e.g., data coordinating centers (DCCs), biospecimen resource cores (BCRs), pathology suites, and TSSs may need to be done. If so, a plan will need to be written describing a recommended approach that will need to be discussed with OBBR for their input and approval. Will also assist in the transition/relocation of some or all subcontractor activities/operations into the permanent caHUB once it is established and directed by OBBR. Likewise, it is the intention that the Director of Quality Management position will be reassigned to the permanent caHUB to continue the work design, establish and manage an appropriate Total Quality Management (TQM) System for the various operations/tasks that will be occurring at Tissue Source Sites (TSSs) and at caHUB, e.g., tissue collection, shipping, sectioning, embedding, pathology review and storage as well as data management (donor clinical information, inventory tracking and results). These activities may need to comply with either Clinical Laboratory Improvement Amendment (CLIA), core Good Manufacturing Practices (cGMP), core Good Laboratory Practices (cGLP), College of American Pathologists (CAP) or International Organization for Standardization (ISO) certification. Associated with all caHUB activities, process QA/QC checks will need to be defined and implemented to ensure that quality procedures are being followed and documented by staff for every task. The Director of Quality Management will be responsible for performing periodic internal audits of all internal caHUB operations and subcontracted activities provided to caHUB and be responsible for document control both for all internal caHUB activities as well as any subcontracted activities.
Requirements
REQUIRED SKILLS: Possession of a Masters degree in a Project management or quality management or other scientific discipline, from an accredited college or university. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. Minimum of 10 years experience in Quality management with 4 years at the management level. Familiarity with a variety of TQM systems, e.g., ISO, CLIA, GMPs, and GLPs. Needs to have been involved in establishing and monitoring multi-site projects that needed a strong TQM system at all locations such as for clinical trials. Familiarity with consenting patients, collecting/processing/storage/shipping of specimens, managing data, designing data checks, data sharing and storage with multiple sites and applying an overall TQM project that addresses every aspect of an operation. Experience in establishing a TQM system in a variety of settings, e.g., academic, pharmaceutical or small and large biotech companies. Needs to function independently and as a member of a very large team. Must be prepared to establish an environment where mentoring and coaching are supported and encouraged. Must have excellent communication skills both verbal and written. Ability to manage and train junior staff that will be involved in day to day oversight of multiple subcontracts and experience in biological research and government contracting. Must have experience using Microsoft Office Suite, including Word, Excel, SharePoint, Outlook. This position is subject to obtaining a Public Trust Clearance.
DESIRED SKILLS: Project Management Skills, Multi-tasker, Able to harmonize existing and new TQPs to work effectively together.
Consider joining the ranks of SAIC’s 45,000 employees who are committed to success and innovation. For immediate consideration, please submit your resume online.
SAIC. All rights reserved. Equal Opportunity Employer
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