Sr. Manager, CQA GLP

Responsibilities

• Support GLP quality compliance systems via established policies and procedures
• Manage GLP quality systems including implementation and maintenance of standards
• Perform audits of external vendors providing GLP related services
• Support the process of GCP/GLP deviations from study protocols or SOPs
• Support internal and external GLP study audits and laboratory compliance audits
• Collaborate with relevant functions to verify data integrity for nonclinical and clinical studies
• Provide quality oversight of contract or internal testing facilities
• Support the development of GLP related SOPs and quality documentation
• Contribute to GLP audits/inspections and coordinate regulatory agency responses

Requirements

• Bachelor’s degree in biology, biochemistry, or life sciences
• Minimum 1 year (Manager) or 3 years (Sr. Manager) of related industry experience in Quality
• 3 years of experience overseeing GLP Quality in laboratories testing biologics
• Working knowledge of FDA, ICH GCP guidelines, and GLP regulations
• Experience with CROs, vendors, and relationship management
• Strong project management skills
• Effective English communication skills

Preferred Qualifications

• Experience performing audits of GLP testing labs
• Experience participating in or hosting regulatory audits
• Experience in auditing activities

About the Company

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, the company develops advanced cell therapies across diverse technology platforms, including CAR-T, TCR-T, and NK cell-based immunotherapy.