Quality Management Analyst

About the role

Quality Management Analyst Hybrid Blu Omega is seeking a Quality Management Analyst to support the National Institute of Allergy and Infectious Diseases (NIAID) within the NIH. This role is responsible for providing independent quality oversight for GxP-regulated computerized systems within enterprise clinical informatics systems support services. Location: Rockville, MD - One day per week onsite. Clearance / Suitability: Public Trust eligibility required.

Blu Omega is a Woman-Owned Small Business (WOSB) delivering technology and cybersecurity solutions to federal agencies and enterprise clients nationwide. Headquartered in Ashburn, VA, we support mission-critical programs across civilian and defense sectors, including health, national security, and regulatory environments. We partner with government agencies and large integrators to provide expertise in cybersecurity operations, cloud and infrastructure modernization, data and analytics, and enterprise IT support.

Responsibilities

• Provide independent quality oversight for the implementation, validation, maintenance, and retirement of GxP-regulated computerized systems
• Apply knowledge of GxP regulations, including CSA and CSV, to guide teams in compliance
• Collaborate with cross-functional stakeholders to ensure systems meet regulatory and quality standards
• Support testing activities, incident management, and validation documentation

Requirements

• 5+ years of experience working in a GxP IT environment or GxP Quality Assurance
• Experience with GxP quality standards and regulatory requirements such as GAMP5, CSA, 21 CFR Part 11, and ICH E6 (R2)
• Direct experience supporting GxP IT projects and testing, including validation plans, IQ/OQ/PQ, and validation documentation
• Experience writing SOPs and providing training to teams and stakeholders
• Ability to obtain Public Trust clearance

Skills

• Experience with electronic test execution software, vendor assessments, and internal audits
• Knowledge of GxP impact assessments, system risk assessments, validation, and 21 CFR Part 11 assessments
• Certified Quality Auditor, Quality Engineer, ISO Lead, or related certification

Benefits

• Medical, Dental, and Vision coverage through national providers
• 401(k) with company match (eligible after 6 months; vesting applies)
• Company-paid Life and AD&D insurance with additional voluntary options
• Short-term disability (company-paid) and long-term disability options
• Employee Assistance Program (EAP) with 24/7 confidential support and mental health resources
• Telehealth and virtual care options available through medical plans
• Pet insurance, legal services, and identity theft protection options
• Paid Time Off (PTO) for eligible employees
• Paid federal holidays for salaried employees
• Access to wellness programs, discounts, and lifestyle benefits

Pay

Salary Range: $82,000.00 - $102,000.00. Final compensation is based on technical skills, experience, education, certifications, and clearance.

Schedule

Hybrid: One day per week onsite in Rockville, MD.