Senior IT GxP & Quality Compliance Analyst

MESO SCALE DIAGNOSTICS, LLC.; Rockville (MD); Hybrid; USD 101,000 - 155,000; Full time

Job summary

MESO Scale Diagnostics, LLC. in Rockville, MD seeks a Senior IT GxP and Quality Compliance Analyst to ensure IT systems, processes, and policies comply with GLP/GCLP and ISO 9001. The role owns IT quality governance, CSV frameworks, validation, and documentation.

You will collaborate with Bioanalytical Lab, QA, Cybersecurity, and Enterprise Systems to drive continual improvement, prepare for inspections, and oversee supplier and platform qualification in a regulated IT environment.

Qualifications

• Bachelor’s degree or equivalent in IT/CS or related field.
• Minimum 6 years of IT in GLP/GCLP environments.
• Direct CSV deliverables authoring/approval experience.
• Experience as quality gatekeeper for computerized systems.

Responsibilities

• Review IT policies and controls for GLP/GCLP compliance.
• Own CSV framework, validation Master Plans, risk-based validation.
• Review validation Deliverables (IQ/OQ/PQ, VSRs, traceability).
• Support audits, host inspectors, and manage audit findings.
• Maintain ISO 9001 alignment and QMS documentation.

Skills

GxP compliance

Quality assurance

Regulatory audits

Document control

SOP authoring

Education

Bachelor’s degree in Information Technology, Computer Science, Information Systems, or related field

Tools

LIMS

eQMS

Regulatory inspection tools

Job description

MESO Scale Diagnostics, LLC. in Rockville, MD seeks a Senior IT GxP and Quality Compliance Analyst to ensure IT systems, processes, and policies comply with GLP/GCLP and ISO 9001. The role owns IT quality governance, CSV frameworks, validation, and documentation.

You will collaborate with Bioanalytical Lab, QA, Cybersecurity, and Enterprise Systems to drive continual improvement, prepare for inspections, and oversee supplier and platform qualification in a regulated IT environment.