Clinical CSV QA Contractor - GxP Validation & Compliance

Katalyst CRO; San Francisco (CA); On-site; USD 124,000 - 179,000; Full time

Job summary

Katalyst CRO is seeking a QA Computer System Validation (CSV) Contractor to support the Quality organization with validation activities focused on clinical GxP systems. You will provide QA oversight and strategic guidance to ensure compliance and successful validation across platforms.

Reporting to the QA leadership, you will coordinate validation projects, manage risk assessments, and help drive inspection readiness.

Qualifications

• Experience leading CSV validation lifecycle for clinical systems.
• Strong knowledge of GxP regulatory requirements and Part 11/Annex 11.
• Hands-on validation of electronic trial master file, eClinical systems, and data integrity practices.

Responsibilities

• Support CSV strategy and validation lifecycle for clinical systems.
• Provide QA oversight for validation projects across GxP platforms.
• Lead risk assessments and mitigation planning with cross-functional teams.
• Review and approve CSV documentation: plans, specs, test protocols, and reports.
• Coordinate vendor assessments, audits, and regulatory inspections readiness.
• Develop and maintain validation SOPs, templates, and processes.

Skills

QA CSV

Clinical Systems Validation

GxP Compliance

21 CFR Part 11

EU Annex 11

Risk-Based Validation

Data Integrity

Audit & Inspection Readiness

Vendor Qualification

Veeva eTMF

Medidata Rave

Clinical Data Repositories

Tools

Veeva eTMF

Medidata Rave

Clinical Data Repositories

Job description

Katalyst CRO is seeking a QA Computer System Validation (CSV) Contractor to support the Quality organization with validation activities focused on clinical GxP systems. You will provide QA oversight and strategic guidance to ensure compliance and successful validation across platforms.

Reporting to the QA leadership, you will coordinate validation projects, manage risk assessments, and help drive inspection readiness.