Columbus · 6 hours ago
Software Quality Assurance Manager (Quality Manager)
United States
Full-time
Remote
Mid, Senior Level
$120K/yr - $160K/yr
6+ years expColumbus Technologies is seeking an experienced Quality Assurance Manager to work remotely in support of NIH. The role involves establishing and maintaining processes for evaluating software and documentation, ensuring quality throughout the software lifecycle, and providing supervision to support staff.
ConsultingInformation Technology
No H1B
Security Clearance RequiredU.S. Citizen Only
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
Qualification
Required
Must be a US Citizen or Permanent Resident
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
Preferred
Prior experience supporting NIH is desired but not required
Benefits
Full benefits
Company
Columbus
Columbus is a consultancy company helping organisations drive business value by defining, executing, and evolving their entire business.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2011-12-15Acquired
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