Senior GLP QA & Audit Manager (Remote)

Merck & Co.; United States; On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Vacation, personal time, sick time & /

Job summary

Legend Biotech USA Inc. is seeking a Sr. Manager, GLP - CQA to join the Regulatory Affairs team and conduct GxP audits across GCP, GLP, GCLP and GVP, ensuring compliance with global regulations while supporting inspection readiness and CAPA activities.

The incumbent may perform audits outside the U.S. (up to 25%). Reports to the Sr. Director of Clinical Quality Assurance with dotted lines to the GCP/GVP AD and GLP Sr. Manager, and will enable continuous quality improvement across functions.

Qualifications

• Minimum 3 years of Quality in the Pharmaceutical industry.
• 3 years of experience with GCP, GVP and GLP Quality in labs testing biologics and CROs.
• Experience performing regulatory audits of GLP labs is a plus.
• Ability to work with CROs, vendors, and manage relationships.
• Strong written and verbal communication in English.

Responsibilities

• Lead or participate in GCP, GLP, and GVP audits across sites.
• Coordinate regulatory inspection support activities (FDA/EMA/MHRA).
• Maintain the risk-based audit program, including CAPA follow-up and tracking.
• Document audit observations and assess responses for adequacy.
• Provide quality oversight of clinical, non-clinical, and pharmacovigilance activities.
• Develop and maintain GxP SOPs, written standards, and QMS documentation.
• Serve as CQA partner to Clinical and Pre-clinical Functions.
• Audit external vendors providing GLP related services and file reports in Veeva.

Skills

GxP quality experience

Auditing GLP labs

Regulatory audits

CRO/vendor management

English communication

Education

Bachelor's degree in biology, biochemistry, or life sciences

Job description

Legend Biotech USA Inc. is seeking a Sr. Manager, GLP - CQA to join the Regulatory Affairs team and conduct GxP audits across GCP, GLP, GCLP and GVP, ensuring compliance with global regulations while supporting inspection readiness and CAPA activities.

The incumbent may perform audits outside the U.S. (up to 25%). Reports to the Sr. Director of Clinical Quality Assurance with dotted lines to the GCP/GVP AD and GLP Sr. Manager, and will enable continuous quality improvement across functions.