Senior GxP Audit & Quality Lead

Legend Biotech US; New Jersey; On-site; USD 130,000 - 170,000; Full time

Job summary

Legend Biotech is seeking a Sr. Manager, GLP - CQA in Somerset, NJ to lead GCP, GLP and GVP audits and support regulatory inspections. You will partner with clinical, non-clinical and QA teams to ensure compliant quality across studies.

The role requires a Bachelor’s degree in life sciences, 3+ years in pharma quality, and travel up to international sites. You will help develop SOPs, CAPAs, and drive continuous quality improvement across the organization.

Qualifications

• Bachelor’s degree in biology, biochemistry, or life sciences.
• Fluency in English.
• Minimum 3 years in Quality in the pharmaceutical industry.
• 3 years auditing GCP, GVP, GLP in labs/CROs.
• Experience with regulatory audits and CRO/vendor management.
• Ability to travel domestically and internationally.

Responsibilities

• Lead or participate in GCP, GLP, and GVP audits.
• Support regulatory inspection activities (FDA, EMA, MHRA, others).
• Develop and maintain GxP SOPs and QMS documents.
• Provide QA oversight of clinical, non-clinical, and pharmacovigilance activities.
• Collaborate with GLP functions to ensure data integrity.
• Mentor and coach business functions on GxP awareness.

Skills

Quality assurance

GxP compliance

Auditing

Regulatory knowledge

Stakeholder mgmt

Communication

Independent worker

Education

Bachelor’s degree in life sciences

Tools

Veeva system

Job description

Legend Biotech is seeking a Sr. Manager, GLP - CQA in Somerset, NJ to lead GCP, GLP and GVP audits and support regulatory inspections. You will partner with clinical, non-clinical and QA teams to ensure compliant quality across studies.

The role requires a Bachelor’s degree in life sciences, 3+ years in pharma quality, and travel up to international sites. You will help develop SOPs, CAPAs, and drive continuous quality improvement across the organization.