Senior QA CSV Lead - GxP Computer Systems

4D Molecular Therapeutics; Emeryville (CA); On-site; USD 126,000 - 145,000; Full time

Job summary

4D Molecular Therapeutics is seeking a Sr. QA Computer System Validation Manager to oversee the validation and lifecycle management of GxP computer systems across clinical, quality, laboratory, enterprise and manufacturing environments.

This role ensures systems are compliant with FDA, 21 CFR Part 11, EU Annex 11, GAMP 5 and ICH guidelines while collaborating with IT and business teams to drive risk-based, compliant CSV activities.

Qualifications

• Bachelor’s degree in life sciences, computer science, business or related field.
• Minimum 5‑7 years in the biopharmaceutical industry.
• Minimum 4 years experience in QA CSV.
• Experience with clinical systems (IRT, EDC, eTMF).
• Knowledge of FDA, EMEA, MHRA regulatory requirements.
• Expertise in 21CFR Part 11 and EU Annex 11, data integrity, GAMP 5.
• Experience supporting regulatory inspections and audits.
• Risk-based approaches to information system selection, testing, maintenance.

Responsibilities

• Provide QA oversight to support business and CSV activities throughout the lifecycle of GxP computer systems.
• Provide Quality oversight of GxP computerized systems including external partner deployments and review CSV deliverables.
• Review and approve CSV deliverables, IT change management requests, and quality records.
• Review plans and provide day‑to‑day QA guidance for validation and change initiatives in clinical systems.
• Serve as SME in CSV requirements, data integrity controls and regulatory standards.
• Assist in development and 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 initiatives and regulatory inspections.
• Other duties as assigned by management.

Skills

Quality Assurance

Regulatory compliance

GxP knowledge

Risk-based approaches

Communication skills

Cross-functional collaboration

Audits and inspections

Documentation control

Education

Bachelor’s degree in life sciences

Tools

21 CFR Part 11

EU Annex 11

GAMP 5

Job description

4D Molecular Therapeutics is seeking a Sr. QA Computer System Validation Manager to oversee the validation and lifecycle management of GxP computer systems across clinical, quality, laboratory, enterprise and manufacturing environments.

This role ensures systems are compliant with FDA, 21 CFR Part 11, EU Annex 11, GAMP 5 and ICH guidelines while collaborating with IT and business teams to drive risk-based, compliant CSV activities.