Sr. Manager, GLP - CQA

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.

From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Sr. Manager, GLP - CQA as part of the Regulatory Affairs team based in Somerset, NJ
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The incumber will support the execution of GxP audit and inspection activities across GCP, GLP, GCLP and GVP, ensuring compliance with applicable global regulations and internal quality standards, while contributing to inspection readiness, SOPs development, and continuous quality improvement initiatives. The incumbent may be assigned to perform audits outside the U.S.A. (max 25% of the time).

• Support and conduct GCP, GLP, and GVP audits as a lead auditor for assigned audits or as ateam member, including internal processes, investigator sites, internal and external GLP studyaudits and general laboratory compliance audits vendors, and service providers
• Contribute to / coordinate regulatory inspection support activities (e.g., FDA, EMA, MHRA,and other Health Authorities), including preparation, coordination, and follow-up actions.
• Support the risk-based audit program, including audit preparation, execution, reporting, andCAPA follow-up and tracking and effectiveness checks.
• Document audit observations, assess responses, and review CAPA evidence for adequacy andtimely closure.
• Provide quality and compliance support to ensure clinical, non-clinical, and pharmacovigilanceactivities are conducted in accordance with GCP, GLP, and GVP requirements.
• Support the development, maintenance, and periodic review of GxP SOPs, written standards,and QMS documentation.
• Act as a CQA partner to the Clinical and Pre-clinical Functions to support the stakeholders by advising on compliance questions, issue resolution, and quality improvement actions.
• Support/perform audits of external vendors that provide GLP related services. The ‘audit’includes all activities, from the set up of the agenda, confirmation letter, review of vendor’sSOPs, etc. to the timely (30 days’ target) filing of the audit report and other relevant documentation in the Veeva system.
• Support the process of GCP/GLP deviations from study protocols or standard operating procedures.
• Collaborate with the GLP’s relevant functions in reviewing relevant data for nonclinical and clinical studies to verity data integrity and to ensure work was performed according to protocols and complied with all relevant regulations.
• Provide quality oversight of contract or internal testing facilities to ensure adherence to all regulations, standard procedures and protocols. Alert the appropriate level of management with any non-compliance issues, ensure all corrective actions take place and elevate concerns when necessary.
• Assist with quality metrics, trend analysis, and reporting to…