Senior CSV QA Leader - Remote (GxP, AI Governance)

BridgeBio Inc.; United States; Remote; USD 145,000 - 170,000; Full time

Job summary

BridgeBio is seeking a Senior Manager, Computer System Validation (CSV), QA to oversee the validation lifecycle for GxP systems ensuring compliance with regulatory standards. The role supports QA oversight of GCP/GVP CSV from design through retirement and collaborates with IT, quality, and stakeholders, including AI governance considerations.

The position requires 8+ years in quality systems within clinical or biotech/pharma sectors, with expertise in 21 CFR Part 11, GAMP, and ICH GCP.

Qualifications

• 8+ years in quality systems within clinical or biotech/pharma sectors.
• Expertise in GxP CSV/CSA and system lifecycle management.
• Knowledge of 21 CFR Part 11, GAMP, ICH GCP.

Responsibilities

• Provide QA oversight of GCP/GVP computer system validation from design through retirement
• Review risk assessments, change controls, validation deliverables
• Participate in audits, support inspection readiness
• Drive continuous improvement of QMS and validated systems
• Collaborate with IT, quality, and functional stakeholders; support AI governance and training

Skills

GxP CSV expertise

System lifecycle management

Regulatory knowledge

Education

Bachelor’s/Master’s in software, engineering, or technical field

Job description

BridgeBio is seeking a Senior Manager, Computer System Validation (CSV), QA to oversee the validation lifecycle for GxP systems ensuring compliance with regulatory standards. The role supports QA oversight of GCP/GVP CSV from design through retirement and collaborates with IT, quality, and stakeholders, including AI governance considerations.

The position requires 8+ years in quality systems within clinical or biotech/pharma sectors, with expertise in 21 CFR Part 11, GAMP, and ICH GCP.