GxP Quality Assurance Lead – IT Systems & Compliance

GAP SOLUTIONS INC; Bethesda (MD); On-site; USD 110,000 - 140,000; Full time

Job summary

GAP Solutions Inc is seeking a Quality Management Specialist to support NIH/NIAID quality systems. You will provide independent quality oversight for GxP computerized systems, ensuring CSA/CSV compliance and validated lifecycle activities.

The role requires 3+ years in a GxP IT QA environment, strong knowledge of 21 CFR Part 11 and ICH E6(R2), and experience writing SOPs, IQ/OQ/PQ, and training cross-functional teams.

Qualifications

• BA or BS degree required.
• 3+ years of quality assurance in a GxP IT environment.
• Experience with GAMP5, Computer Software Assurance, 21 CFR Part 11, and ICH E6 (R2).
• Experience writing SOPs and IQ/OQ/PQ documents.
• Ability to obtain Public Trust clearance.

Responsibilities

• Provide independent quality oversight for GxP regulated computerized systems.
• Guide teams in CSA/CSV compliance and validation activities.
• Develop and review SOPs, IQ/OQ/PQ, and validation plans.

Skills

GxP QA

GxP IT experience

Test incident management

SOP writing

Training others

Cross-functional collaboration

Quality oversight

Education

BA/BS degree

Tools

Electronic test execution software

Job description

GAP Solutions Inc is seeking a Quality Management Specialist to support NIH/NIAID quality systems. You will provide independent quality oversight for GxP computerized systems, ensuring CSA/CSV compliance and validated lifecycle activities.

The role requires 3+ years in a GxP IT QA environment, strong knowledge of 21 CFR Part 11 and ICH E6(R2), and experience writing SOPs, IQ/OQ/PQ, and training cross-functional teams.