BACKGROUND:
Lockheed Martin provides clients with top-quality information technology (IT), business management, and scientific solutions. Working in partnership with our Civilian Government, national security, and life sciences clients, we deliver innovative, on-target solutions that support our clients’ vital missions, goals, and objectives. Among our proven capabilities are systems design, development, and integration; systems engineering; application support, IT infrastructure management; professional services; management consulting; and specialized health and bioinformatics services.

RESPONSIBILITIES:
We are currently searching for a Quality Assurance Program Manager to support the National Institutes of Health (NIH). This opportunity is a permanent, full-time position with Lockheed Martin and it is on-site in Gaithersburg, MD.

Duties:

• Responsible for establishment of the QA practices. Assures approaches used throughout the program meet regulatory requirements, minimize business risks, are consistent with industry standards, and efficiently use available resources and time
• Responsible for total Quality Assurance of the operation in accordance with US Code of Federal Regulation (CFR) and guidelines for Good Clinical Laboratory Practices (GCLP)
• Assures systems, policies, procedures, staff and training are in place to assure conformance on an ongoing basis
• Manages SOPs and controlled documents
• Manage the CAPA, Deviation and Atypical Result Investigation/Reporting system
• Effectively manage regulatory inspections. Respond to inspection reports and maintain correspondence with third party inspection teams.
• Assures facility, equipment and assay validations meet regulatory requirements
• Design, conduct, and report on internal audits which make realistic evaluations of compliance status and risk, based upon sound scientific understanding, regulatory requirements and SOP’s. Provide clear reports of this information to senior management.
• Cooperate and collaborate with other DAIDS (or other study sponsor) QA groups.
• Manages external QA oversight, either directly or via contractors, to assure all DAIDS (or other study sponsor) extramural sites are operational under GCLP practices as applied to human clinical trials: inclusive of site audits
• Provide advice and support to help sites establish best practices.
• Track site compliance with corrective actions resulting from site audits.
• Provide DAIDS (or other study sponsor) status reports on all aspects of the site audits and follow ups.
• Identify internal QA deficiencies and recommend rapid resolutions.
• Assess all information, regulations, customer and needs prior to providing expert guidance and advice for problem resolution.
• Manage 2-3 Quality Assurance Assistant positions.
• Administer an electronic/automated Quality Assurance System.
• Perform other duties as required.

REQUIREMENTS:

• Knowledge of US CFR and ISH guidelines for Good Laboratory Practices.
• Working understanding of immunology and biological sciences
• OHSA requirements for safe laboratory practices

LOCALE: Gaithersburg, MD

SALARY & COMPENSATION:
Salary commensurate with experience. There is much to be said about the Lockheed Martin Total Value package. Part of the package involves a commitment to develop top talent from within as well as provide access to a wide range of training programs and services. There is also the opportunity to work in exceptional environments marked by: Project Significance, Quality People, Recognition, Learning and Development, Internal Career Mobility, Competitive Pay, and Excellent Benefits.

A commitment to your work/life balance.

Part of the Lockheed Martin experience includes a focus on work/life satisfaction. We offer programs and policies that include: Flexible/Alternative Work Schedules and Casual Dress at many locations, Telecommuting, Tuition Assistance, Employee Assistance Program, Fitness Centers, Birth/Adoption Leave, Domestic Partner Benefits, and Adoption Assistance.

At Lockheed Martin, we are driven by innovation and integrity. We believe that by applying the highest business ethics and visionary thinking - everything is within our reach, and yours.

We invite you to explore the possibilities with one of the foremost systems engineering, software and systems integration companies in the world.

An Equal Opportunity Employer.

HOW TO APPLY:
Please visit and apply via our careers page http://www.lockheedmartin.com/careers and enter Req ID 151089 in the Job Search tool. Or, you may directly apply via the following link:
https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=25037&siteid=5010&AReq=151089BR&Codes