GxP IT Compliance Lead - CSV & ISO 9001

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan with company matching

Paid vacation and holidays

Flexible spending accounts

Job summary

Meso Scale Diagnostics LLC is seeking an IT compliance leader to ensure systems, processes, and policies meet GLP/GCLP requirements, with responsibility for CSV governance within the Bioanalytical Lab context.

The role covers risk assessments, audit support, and regulatory interactions, including 21 CFR Part 11 and EU Annex 11 alignment, while maintaining ISO 9001 readiness across IT functions.

Qualifications

• Bachelor’s degree plus at least 6 years in IT within GLP/GCLP environments.
• Direct CSV deliverables authoring or approval experience.
• Experience supporting ISO 9001 certification or audits preferred.
• Experience in IT governance, risk management, and audit processes.

Responsibilities

• Review IT policies to ensure GLP/GCLP compliance.
• Maintain CSV framework including validation plans and risk-based strategies.
• Review/approve validation deliverables and traceability matrices.
• Conduct risk assessments for GxP IT systems.
• Support audits by preparing evidence and closing findings.
• Serve as IT liaison for regulatory inspections and sponsor audits.
• Oversee IT GxP self-inspections and supplier oversight.
• Maintain GxP compliance docs and provide training guidance.
• Interpret 21 CFR Part 11, EU Annex 11, GAMP 5 and related standards.
• Author and control IT SOPs, templates, and policies.
• Manage nonconformities and CAPA with verified effectiveness.
• Define/report IT quality KPIs and prepare management input.
• Support ISO 9001 certification activities and surveillance audits.

Skills

CSV deliverables

GxP compliance

Regulatory inspections

ISO 9001 quality mgmt

SaaS/regulatory IT

Policy governance

Education

Bachelor's degree in IT/CS or related field

Tools

LIMS

eQMS

Job description

Meso Scale Diagnostics LLC is seeking an IT compliance leader to ensure systems, processes, and policies meet GLP/GCLP requirements, with responsibility for CSV governance within the Bioanalytical Lab context.

The role covers risk assessments, audit support, and regulatory interactions, including 21 CFR Part 11 and EU Annex 11 alignment, while maintaining ISO 9001 readiness across IT functions.