NIH NIAID Software – Quality Assurance Manager (Quality Manager)

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.

General Description of Benefits

• 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.