Remote Senior CQA Lead Auditor - Quality & Compliance

Legend Biotech, Inc.; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Legend Biotech is seeking a Sr. Manager, CQA Lead Auditor to support GxP audit and inspection activities globally, with up to 25% international travel. The role requires leading internal and external audits, developing CAPA plans, and ensuring compliance with GCP, GLP, and GVP across clinical and non-clinical programs.

The incumbent will report to the Sr. Director of Clinical Quality Assurance, partnering with Clinical and Pre-clinical teams to drive quality improvements and inspection readiness

Qualifications

• Bachelor's degree in biology, biochemistry, or life science is required.
• Minimum 3 years of quality/QA experience in pharma, with GCP/GVP/GLP exposure.
• Strong English communication and ability to work with CROs and vendors.

Responsibilities

• Lead or participate in GCP, GLP, and GVP audits across studies and vendors.
• Support regulatory inspections (FDA/EMA/MHRA) including preparation and follow-up actions.
• Develop and maintain GxP SOPs and QMS documentation.
• Provide quality guidance to Clinical and Pre-clinical functions.

Skills

GxP Auditing

GCP/GVP/GLP

Regulatory inspections

English communication

Audit leadership

Vendor/CRO management

Education

Bachelor's degree in biology/biochemistry/life science

Tools

Veeva system

CAPA tracking

Job description

Legend Biotech is seeking a Sr. Manager, CQA Lead Auditor to support GxP audit and inspection activities globally, with up to 25% international travel. The role requires leading internal and external audits, developing CAPA plans, and ensuring compliance with GCP, GLP, and GVP across clinical and non-clinical programs.

The incumbent will report to the Sr. Director of Clinical Quality Assurance, partnering with Clinical and Pre-clinical teams to drive quality improvements and inspection readiness