ECS is seeking an experienced NIH NIAID Enabling and Advancing Technologies (NEAT) Quality Assurance Manager to work remotely. Please Note: This position is contingent upon contract award.
The NIAID NEAT Quality Assurance Manager establishes and maintains a process for evaluating software and associated documentation. The QM determines the resources required for quality control and maintains the level of quality throughout the software life cycle. Conducts formal and informal reviews at pre-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 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.
Salary Range: $120,000 - $160,000
General Description of Benefits
Preferred Qualifications- 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.
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What We Do
ECS, a segment of ASGN (NYSE: ASGN), delivers advanced solutions and services in cloud, cybersecurity, artificial intelligence (AI), machine learning (ML), application and IT modernization, and science and engineering. The company solves critical, complex challenges for customers across the U.S. public sector, defense, intelligence and commercial industries. ECS maintains partnerships with leading cloud, cybersecurity, and AI/ML providers and holds specialized certifications in their technologies. Headquartered in Fairfax, Virginia, ECS has more than 3,400 employees throughout the U.S. and has been recognized as a Top Workplace by The Washington Post for the last five years.
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