IT GxP & Quality Compliance Specialist

Meso Scale Diagnostics; Rockville (MD); Hybrid; USD 101,000 - 155,000; Full time

Benefits offered by this job

401(k) with company match

Disability insurance

Paid time off

Job summary

Meso Scale Diagnostics seeks an Information Technology GxP and Quality Compliance Analyst to ensure IT systems, processes, and controls meet GLP/GCLP and ISO 9001 standards. You will own CSV validation, policy governance, and support audits with cross-functional teams in a hybrid work setting.

The role requires 6+ years in IT within regulated environments and strong knowledge of 21 CFR Part 11, GAMP 5, and quality management systems. Collaborate with Bioanalytical Lab and QA teams.

Qualifications

• Advanced knowledge of IT governance, risk management, security frameworks, and audit processes in GLP/GCLP.
• Deep understanding of GxP compliance requirements for computerized systems.
• Experience supporting regulatory inspections or sponsor audits, and CSV deliverables.

Responsibilities

• Review IT policies, procedures, and controls for GLP/GCLP compliance.
• Own and maintain CSV framework including validation master plans and risk-based strategies.
• Assist audits by preparing evidence and tracking remediation efforts.
• Serve as IT contact for regulatory inspections and sponsor audits.
• Maintain ISO 9001 documentation, training, and continual improvement.

Skills

IT governance

GxP compliance

Regulatory inspections

Risk assessment

Quality metrics

Education

Bachelor's degree in Information Technology or related field

Tools

LIMS

eQMS

ISO 9001

Job description

Meso Scale Diagnostics seeks an Information Technology GxP and Quality Compliance Analyst to ensure IT systems, processes, and controls meet GLP/GCLP and ISO 9001 standards. You will own CSV validation, policy governance, and support audits with cross-functional teams in a hybrid work setting.

The role requires 6+ years in IT within regulated environments and strong knowledge of 21 CFR Part 11, GAMP 5, and quality management systems. Collaborate with Bioanalytical Lab and QA teams.