Remote CSV QA Leader - GxP Systems & AI Governance

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

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Hybrid work model

100% employer-paid medical, dental, &

Job summary

BridgeBio Pharma seeks a Senior Manager, CSV QA to lead validation of GxP computer systems across QA Ops. You will oversee lifecycle activities from design to retirement, ensuring health-authority compliance and data integrity.

In this remote-USA role, you will partner with IT, QA, and business owners to drive risk-based validation, changes, CAPA, and inspections readiness. Travel to SF quarterly for in-person collaboration is expected.

Qualifications

• Bachelor’s or Master’s degree in software, computer engineering, or technical field.
• 8+ years of experience in quality systems development and maintenance within pharmaceutical or biotech settings.
• Strong attention to detail and organizational skills.
• Effective written and verbal communication.
• Expertise in GxP computerized system validation/assurance and lifecycle management.
• Knowledge of 21 CFR Part 11, EU Annex 11, ICH GCP, EU GVP, and risk-based lifecycle practices.
• Experience with AI/LLMs and AI governance in a GxP setting is a plus.

Responsibilities

• Provide QA oversight of GCP/GVP CSV lifecycle across design, configuration, updates, and maintenance.
• Review risk assessments to determine scope and level of validation.
• Approve IT change control and validation deliverables including protocols and reports.
• Lead periodic system and user reviews; identify and remediate compliance gaps.
• Collaborate with IT and business owners to enforce validation and data integrity standards.
• Support audit programs; participate in audit reports and CAPA reviews.
• Project-manage implementation and enhancement of GCP/GVP and QMS systems.
• Drive continuous improvement for QMS and validated GxP systems.
• Assist with inspection readiness and regulatory inspections as QA CSV SME.

Skills

GxP CSV/CSA

Regulatory compliance

Quality systems

Cross-functional collaboration

Audits & CAPA

Documentation & SOPs

GxP data integrity

AI governance exposure

Independent work

Education

Bachelor’s or Master’s degree in software, computer engineering, or technical field

Job description

BridgeBio Pharma seeks a Senior Manager, CSV QA to lead validation of GxP computer systems across QA Ops. You will oversee lifecycle activities from design to retirement, ensuring health-authority compliance and data integrity.

In this remote-USA role, you will partner with IT, QA, and business owners to drive risk-based validation, changes, CAPA, and inspections readiness. Travel to SF quarterly for in-person collaboration is expected.