Senior CSV QA Leader - GxP Systems & Compliance

bridgebio; United States; On-site; USD 160,000 - 230,000; Full time

Job summary

BridgeBio is seeking a Senior Manager, CSV QA to oversee the GxP computer system validation lifecycle across design, implementation and retirement. You will ensure validation of GCP/GVP systems and maintain compliance with Health Authority requirements.

The role partners with IT, QA Ops, and business owners to implement risk-based validation, data integrity, and ongoing system maintenance, while supporting audits and CAPA processes.

Qualifications

• 8+ years of quality systems development in pharma/biotech.
• Expertise in GxP computerized system validation/assurance (CSV/CSA).
• Knowledge of 21 CFR Part 11, EU Annex 11, ICH GCP, EU GVP.
• AI/Large Language Models governance experience is a plus.

Responsibilities

• Provide QA oversight of the GCP/GVP validation lifecycle from design to retirement.
• Review and approve risk assessments to determine scope of validation.
• Review and approve IT change control and validation deliverables (protocols, test scripts, reports).
• Participate in periodic system and user reviews; remediate compliance gaps.
• Collaborate with IT and business owners to enforce validation requirements and data integrity.
• Support audit program; participate in audit and CAPA reviews.
• Project manage implementation and enhancement of GCP/GVP and QMS systems.
• Drive continuous improvement of QMS and validated GxP systems.
• Support inspection readiness and regulatory inspections as QA CSV SME.

Skills

Quality systems

GxP CSV/CSA

Regulatory compliance

Cross-functional collaboration

AI governance (GxP)

Education

Bachelor's or Master's in software/engineering/technical field

Job description

BridgeBio is seeking a Senior Manager, CSV QA to oversee the GxP computer system validation lifecycle across design, implementation and retirement. You will ensure validation of GCP/GVP systems and maintain compliance with Health Authority requirements.

The role partners with IT, QA Ops, and business owners to implement risk-based validation, data integrity, and ongoing system maintenance, while supporting audits and CAPA processes.