Remote Senior CQA Lead Auditor: GxP Compliance & Audits

BioSpace; United States; Remote; USD 146,000 - 192,000; Full time

Benefits offered by this job

401(k) match with company contribution

Eight weeks parental leave

Paid time off + 11 company holidays

Job summary

Legend Biotech, headquartered in Bridgewater, NJ, is seeking a Sr. Manager, CQA Lead Auditor to support GCP, GLP, and GVP audits as a lead auditor for assigned studies and vendors. You will coordinate regulatory inspection activities and ensure compliance across clinical and non-clinical programs.

The role requires a Bachelor's in biology or life sciences, 3+ years of relevant QA experience, and strong communication skills. Willingness to travel domestically and internationally is expected.

Qualifications

• 3+ years in Quality with GCP/GVP/GLP.
• Experience auditing GLP labs and CROs preferred.
• Strong English communication and cross-functional collaboration.

Responsibilities

• Lead and support GCP, GLP, and GVP audits for internal and external providers.
• Prepare for regulatory inspections and coordinate responses and CAPAs.
• Maintain GxP SOPs and QMS documentation with QA teams.
• Provide quality oversight for clinical and non-clinical activities.
• Partner with Clinical/Pre-clinical functions to resolve compliance issues and drive improvements.

Skills

GCP audits

GLP audits

GVP audits

Regulatory liaison

Education

Bachelor's in biology/life sciences

Tools

Veeva

Job description

Legend Biotech, headquartered in Bridgewater, NJ, is seeking a Sr. Manager, CQA Lead Auditor to support GCP, GLP, and GVP audits as a lead auditor for assigned studies and vendors. You will coordinate regulatory inspection activities and ensure compliance across clinical and non-clinical programs.

The role requires a Bachelor's in biology or life sciences, 3+ years of relevant QA experience, and strong communication skills. Willingness to travel domestically and internationally is expected.