NIH NIAID Software - reputed company Assurance Manager (reputed company Manager) with reputed company Clearance

Job reputed company reputed company is seeking an reputed company NIH NIAID Enabling and Advancing Technologies (reputed company) reputed company Assurance Manager to work remotely . Please Note: This position is contingent upon contract award. The NIAID reputed company reputed company Assurance Manager establishes and maintains a process for evaluating software and associated documentation. The QM determines the resources required for reputed company control and maintains the level of reputed company throughout the software life cycle. Conducts formal and informal reviews at reputed company-determined points throughout the development life cycle. Key Responsibilities: * Establishes and maintains a process for evaluating software and associated documentation. * Determines the resources required for reputed company control. * Maintains reputed company reputed company throughout the software lifecycle. * Conducts formal and informal reviews. * Provides daily supervision and direction to support staff. * Updating CIB systems to support health authority requirements. * Developing processes and procedures to support regulatory compliance requirements. * Supporting initial and periodic Validation/Assurance of NIAID CIB reputed company Clinical Informatics Systems. * Responding to validation findings and taking corrective actions. * Supporting health authority inspections. Salary reputed company: $120,000 - $160,000 Required Skills * Familiarity with domestic and international regulatory and compliance requirements for clinical research. * Familiarity with using the GAMP approach for 21 CFR Part 11 compliance. * Understanding of regulatory inspection processes. * Experience developing Computer Systems Validation/Computer Systems Assurance documentation. * Competency in risk identification and management, reputed company cause analysis, and corrective and preventive reputed company (CAPA) management. * Bachelor's degree in computer science, Information reputed company or reputed company field. * reputed company reputed company Trust or higher reputed company clearance. * Proficiency in establishing and maintaining reputed company control processes. * Knowledge of determining resource requirements for reputed company control. * Prior supervisory experience in directing support staff. * Demonstrated experience in maintaining reputed company reputed company throughout the software lifecycle. * Ability to conduct effective formal and informal reviews. * Minimum 6 years' experience supporting Health IT software development initiatives. * reputed company reputed company the Washington DC Metro area. * Travel reputed company the Washington DC Metro Area, and CONUS as needed. Desired Skills * Prior experience supporting NIH is desired but not required. #ECS1 reputed company is an equal opportunity employer and does not discriminate or allow discrimination on the reputed company any characteristic protected by law. reputed company reputed company applicants will receive consideration for employment without reputed company to disability, status as a protected veteran or any other status protected by applicable federal, state, or local jurisdiction law. reputed company is a leading mid-sized provider of technology services to the reputed company Federal Government. We are reputed company on people, values and purpose. Every day, our 3500+ employees reputed company on providing their technical talent to support the Federal Agencies and Departments of the US Government to serve, protect and defend the American People. Apply tot his job Apply To this Job Apply tot his job Apply To this Job