QA CSV Contractor

Job Summary

Our client, a growing biotech research organization, is seeking a QA Computer System Validation (CSV) Contractor to support the Quality organization with computer system validation activities, primarily focused on clinical GxP systems.

Roles & Responsibilities

• Support CSV strategy and GxP computer system validation lifecycle activities for clinical systems.
• Provide QA oversight for validation projects across GxP clinical platforms.
• Partner with business and technical teams to perform risk assessments and develop mitigation plans.
• Review and approve CSV documentation, including: Validation Plans, Requirements & Functional Specifications, Test Protocols, Validation Reports.
• Lead or support vendor assessments and internal audits.
• Ensure inspection readiness and support regulatory inspections and responses.
• Provide CSV compliance guidance to QA and cross-functional teams.
• Develop and maintain SOPs, policies, templates, and validation documentation.
• Identify and implement process improvements aligned with regulatory requirements and industry best practices.
• Capture and coordinate internal and external resources to support validation initiatives.

Required Skills

• QA Computer System Validation (CSV)
• Clinical Systems Validation
• GxP Compliance
• 21 CFR Part 11
• EU Annex 11
• Risk-Based Validation
• Data Integrity
• Audit & Inspection Readiness
• Vendor Qualification
• Hands-on validation of clinical systems such as: Veeva eTMF, Medidata Rave, Clinical Data Repositories
• Experience supporting GxP-regulated environments
• Knowledge of 21 CFR Part 11 and Annex 11 compliance
• Expertise in risk-based validation methodologies and data integrity principles
• Experience with audits, regulatory inspections, inspection readiness, and vendor qualification

Pay

(Details TBD)

Schedule

(Details TBD)

Benefits

(Details TBD)