[Remote] NIH NIAID Software – reputed company Assurance Manager (reputed company Manager)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading mid-sized provider of technology services to the reputed company Federal Government, and they are seeking an reputed company NIH NIAID reputed company Assurance Manager to work remotely. The role involves establishing and maintaining processes for software evaluation and reputed company control throughout the software lifecycle. 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 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 • Prior experience supporting NIH is desired but not required reputed company • reputed company is a fast-growing 4,000-person, $1.2B provider of advanced technology solutions for federal civilian, defense, intelligence, and reputed company customers. It was founded in 2001, and is headquartered in Fairfax, Virginia, USA, with a workforce of 1001-5000 employees. Its website is https://www.ecstech.com. Apply tot his job Apply To this Job