Sr. Manager, CQA GLP
The Sr. Manager, CQA GLP at Legend Biotech is responsible for ensuring that nonclinical studies comply with Good Laboratory Practice (GLP) regulations and health authority guidelines. This role involves maintaining a compliant quality system, overseeing laboratory processes, and supporting bioanalytical assays required for GLP studies. The position is based in Somerset, New Jersey, with a hybrid work schedule of 2-3 days on-site.
Key responsibilities include managing GLP quality systems through established policies and procedures, performing audits of external vendors providing GLP-related services, and supporting internal and external GLP study audits to ensure laboratory compliance. The role also involves collaborating with relevant functions to review data for nonclinical and clinical studies, providing quality oversight of contract or internal testing facilities, and contributing to the development of GLP-related standard operating procedures (SOPs).
The ideal candidate holds a bachelor's degree in biology, biochemistry, or life sciences and has a minimum of 3 years of experience for the Sr. Manager level or 1 year for the Manager level. Proficiency in English communication is required. Experience in GLP compliance, quality systems management, and laboratory audits is essential.
Legend Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) retirement plan with company match, paid parental leave, and a generous paid time off policy. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, and various supplemental plans.
Joining Legend Biotech means becoming part of a global biotechnology company dedicated to treating life-threatening diseases through advanced cell therapies. The company fosters a collaborative and innovative work environment, providing opportunities for professional growth and development in the rapidly evolving field of immunotherapy.
The base pay range for this position is $142,146 - $186,567 USD.