GxP Quality Assurance Lead - CSV/CSA Expert

GAP Solutions, Inc.; Bethesda, Northern (MD, KY); Hybrid; USD 75,000 - 105,000; Full time

Job summary

GAP Solutions, Inc. is hiring a Quality Management Specialist to support NIH/NIAID programs in Bethesda, MD.

The role provides independent quality oversight for GxP computerized systems and ensures compliance with CSA/CSV, 21 CFR Part 11 and related standards. The ideal candidate has a BA/BS and 3+ years of quality assurance in a GxP IT environment, with experience writing SOPs, validation plans, and conducting risk assessments.

Qualifications

• BA/BS degree required.
• 3+ years of quality assurance experience in a GxP IT environment.
• Experience with GxP regulations such as 21 CFR Part 11 and ICH E6(R2).
• Experience writing SOPs and/or reviewing validation plans (IQ/OQ/PQ).

Responsibilities

• Provide independent quality oversight for the implementation, validation, maintenance, and retirement of GxP regulated computerized systems.
• Apply knowledge of GxP regulations (CSA, CSV) to guide teams in compliance expectations.
• Recommend and collaborate on solution approaches with cross-functional stakeholders to ensure regulatory and quality standards are met.

Skills

Quality assurance

GxP IT environment

SOP writing/review

Cross-functional training/coordination

Education

Bachelor's degree

Tools

Electronic test execution software

Job description

GAP Solutions, Inc. is hiring a Quality Management Specialist to support NIH/NIAID programs in Bethesda, MD.

The role provides independent quality oversight for GxP computerized systems and ensures compliance with CSA/CSV, 21 CFR Part 11 and related standards. The ideal candidate has a BA/BS and 3+ years of quality assurance in a GxP IT environment, with experience writing SOPs, validation plans, and conducting risk assessments.