Senior CQA Lead Auditor - Remote, Global Compliance

BioNJ Inc.; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Full-time employee benefits

Job summary

Legend Biotech is seeking a Sr. Manager, CQA Lead Auditor to join the Regulatory Affairs team, delivering GxP audits across GCP, GLP, GVP and regulatory inspections. This role offers remote work with occasional travel and a focus on quality compliance in a global environment.

As a lead auditor, you will develop SOPs, support inspection readiness, CAPA, and vendor audits, while ensuring adherence to global regulations. The incumbent will report to the Sr.

Qualifications

• Bachelor's degree in biology, biochemistry, or life sciences.
• Minimum 3 years of experience in pharmaceutical quality.
• 3 years in GCP, GVP and GLP quality
• Experience auditing GLP labs and hosting regulatory audits
• Willingness to travel domestically and internationally and work remotely

Responsibilities

• Lead or participate in GCP/GLP/GVP audits as lead auditor or team member.
• Coordinate regulatory inspection support activities (FDA, EMA, MHRA, etc.).
• Support risk-based audit program, CAPA, and tracking.
• Document audit observations and review CAPA evidence for closure.
• Provide quality support to GxP activities and QMS documentation.
• Develop and maintain GxP SOPs and written standards.
• Advise on compliance questions and quality improvements.
• Audit external vendors and manage Veeva documentation area.

Skills

GxP audits

GCP/GVP/GLP quality

Regulatory inspections

Stakeholder management

Lead auditor

Education

Bachelor's degree in biology/biochemistry/life sciences

Job description

Legend Biotech is seeking a Sr. Manager, CQA Lead Auditor to join the Regulatory Affairs team, delivering GxP audits across GCP, GLP, GVP and regulatory inspections. This role offers remote work with occasional travel and a focus on quality compliance in a global environment.

As a lead auditor, you will develop SOPs, support inspection readiness, CAPA, and vendor audits, while ensuring adherence to global regulations. The incumbent will report to the Sr.