CQA Lead Auditor – Senior Manager, GxP Compliance (Remote)

Legend Biotech US; New Jersey; Remote; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan

Paid parental leave

Extensive PTO

Job summary

Legend Biotech US is seeking a Sr. Manager, CQA Lead Auditor to join the Regulatory Affairs team on a remote basis.

The role supports GxP audits across GCP, GLP, and GVP, ensuring compliance with global regulations and internal standards, with up to 25% travel outside the U.S. You will lead audits, coordinate regulatory inspections, manage CAPA, and contribute to SOP and QMS improvements while partnering with Clinical and Pre-clinical functions to strengthen quality.

Qualifications

• Bachelor’s degree in biology, biochemistry, or the life science.
• Must be able to communicate effectively in English.
• A minimum of 3 years of related industry experience in Quality in the Pharmaceutical industry.
• 3 years of experience in working and/or overseeing GCP, GVP and GLP Quality in laboratories testing biologics, as well as CROs.
• Experience performing audits of GLP testing labs is a plus.
• Experience with participation in and hosting regulatory audits.
• Experience working with CROs, vendors, and relationship management.
• Ability and desire to work well with diverse employees and customers in a cooperative and supportive manner.

Responsibilities

• Lead or participate in GCP, GLP, and GVP audits as a lead auditor for assigned audits or as a team member.
• Coordinate regulatory inspection support activities (FDA, EMA, MHRA, and others).
• Support the risk-based audit program, including audit preparation, execution, reporting, and CAPA follow-up and tracking.
• Document audit observations, assess responses, and review CAPA evidence for adequacy and timely closure.
• Provide quality oversight to ensure clinical, non-clinical, and pharmacovigilance activities comply with GCP, GLP, and GVP.
• Develop and maintain GxP SOPs, written standards, and QMS documentation.
• Act as a CQA partner to Clinical and Pre-clinical functions to support compliance questions and quality improvements.
• Support audits of external vendors providing GLP services and manage audit reports in Veeva.
• Assist with quality metrics, trend analysis, and reporting to identify compliance risks.
• Deliver training and coaching to promote GxP awareness.

Skills

GxP audits

GCP audits

GLP audits

GVP audits

Regulatory inspections

CAPA management

SOPs & QMS

CQA partnership

Vendor & CRO oversight

Education

Bachelor’s degree in biology/biochemistry/life sciences

Tools

Veeva

Job description

Legend Biotech US is seeking a Sr. Manager, CQA Lead Auditor to join the Regulatory Affairs team on a remote basis.

The role supports GxP audits across GCP, GLP, and GVP, ensuring compliance with global regulations and internal standards, with up to 25% travel outside the U.S. You will lead audits, coordinate regulatory inspections, manage CAPA, and contribute to SOP and QMS improvements while partnering with Clinical and Pre-clinical functions to strengthen quality.