Senior QA CSV Lead: GxP Systems & Compliance

BioSpace; United States; On-site; USD 126,000 - 145,000; Full time

Job summary

4DMT is seeking a Sr. QA Computer System Validation Manager to oversee validation and lifecycle management of GxP computer systems across GCP, GMP and GLP environments. This role ensures systems comply with FDA, 21 CFR Part 11, EU Annex 11, and GAMP 5 while supporting audits and inspections.

The position partners with IT and business teams to drive risk-based CSV strategies and maintain lifecycle compliance for clinical, quality, lab, enterprise and manufacturing systems.

Qualifications

• Bachelor’s degree as stated in the qualifications.
• Minimum 5-7 years in biopharmaceutical industry, with exposure to both large and small companies.
• Minimum 4 years experience in QA CSV.
• Strong experience supporting computer systems used in clinical trials through all phases of development.
• Extensive experience supporting validation of clinical systems (e.g. IRT, EDC, eTMF).
• Thorough working knowledge of computer systems validation and computer software assurance.
• Experience with enterprise, quality, lab and clinical systems ensuring regulatory compliance.
• Expertise in 21 CFR Part 11 and EU Annex 11, data integrity, and GAMP 5 concepts.

Responsibilities

• Provide QA oversight to support business and CSV activities throughout the lifecycle of GxP computer systems.
• Quality oversight of GxP computerized systems hosted or managed by external partners, and review CSV deliverables.
• Review CSV deliverables, IT change management requests, and quality records to ensure regulatory compliance.
• Provide day-to-day QA guidance for validation activities and controlled change initiatives.
• Serve as SME in CSV requirements and related regulatory standards.
• Assist in development or refinement of QA/CSV procedures and templates.
• Support audits for qualification and requalification of IT vendors.
• Collaborate across functions to identify improvements and implement enhancements.
• Support inspection readiness and regulatory inspections.
• Other duties as assigned by management.

Skills

GxP CSV

FDA 21 CFR Part 11

ICH Guidelines

Data Integrity

Audit Support

Vendor Management

Risk-based Approach

Education

Bachelor’s degree in life sciences, computer science, business or related field

Job description

4DMT is seeking a Sr. QA Computer System Validation Manager to oversee validation and lifecycle management of GxP computer systems across GCP, GMP and GLP environments. This role ensures systems comply with FDA, 21 CFR Part 11, EU Annex 11, and GAMP 5 while supporting audits and inspections.

The position partners with IT and business teams to drive risk-based CSV strategies and maintain lifecycle compliance for clinical, quality, lab, enterprise and manufacturing systems.