[Remote] NIH NIAID Software – Quality Assurance Manager (Quality Manager)

Note: The job is a remote job and is open to candidates in USA. ECS is a leading mid-sized provider of technology services to the United States Federal Government, and they are seeking an experienced NIH NIAID Quality Assurance Manager to work remotely. The role involves establishing and maintaining processes for software evaluation and quality control throughout the software lifecycle. Responsibilities • Establishes and maintains a process for evaluating software and associated documentation • Determines the resources required for quality control • Maintains quality levels 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 Enterprise Clinical Informatics Systems • Responding to validation findings and taking corrective actions • Supporting health authority inspections 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, root cause analysis, and corrective and preventive action (CAPA) management • Bachelor's degree in computer science, Information Security or related field • Active Public Trust or higher security clearance • Proficiency in establishing and maintaining quality control processes • Knowledge of determining resource requirements for quality control • Prior supervisory experience in directing support staff • Demonstrated experience in maintaining quality levels throughout the software lifecycle • Ability to conduct effective formal and informal reviews • Minimum 6 years' experience supporting Health IT software development initiatives • Reside within the Washington DC Metro area • Travel within the Washington DC Metro Area, and CONUS as needed • Prior experience supporting NIH is desired but not required Company Overview • ECS is a fast-growing 4,000-person, $1.2B provider of advanced technology solutions for federal civilian, defense, intelligence, and commercial customers. It was founded in 2001, and is headquartered in Fairfax, Virginia, USA, with a workforce of 1001-5000 employees. Its website is Apply tot his job