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ECS · 1 week ago

NIH NIAID Software – Quality Assurance Manager (Quality Manager)

United States

Full-time

Remote

Mid, Senior Level

$120K/yr - $160K/yr

6+ years exp

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.

Artificial Intelligence (AI)Cloud InfrastructureComplianceConsultingCyber SecurityInformation TechnologyMachine LearningSecuritySoftware

No H1B

Security Clearance Required

U.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

Quality control processesComputer Systems ValidationRegulatory complianceRisk managementSupervisory experienceBachelor’s degreePublic Trust clearanceEffective reviewsHealth IT experience

Required

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

Company

ECS

Glassdoor3.6

ECS is a fast-growing 4,000-person, $1.2B provider of advanced technology solutions for federal civilian, defense, intelligence, and commercial customers.

Founded in 2001

Fairfax, Virginia, USA

1001-5000 employees