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.
This role will provide QA oversight and strategic support for validation projects, ensuring compliance with regulatory requirements while supporting business objectives. The ideal candidate has extensive experience in QA CSV within the clinical biotech/pharmaceutical industry and can work effectively in a fast-paced, cross-functional environment.
Reporting to the Director of QA CSV, you will oversee validation activities, ensure compliance, and support execution of CSV initiatives across clinical 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.
- 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
- Strong QA Computer System Validation (CSV) experience.
- 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.
