BioNJ

Legend Biotech is seeking a Sr. Manager, CQA Lead Auditor as part of the Regulatory Affairs team based Remotely . Role Overview 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). Key Responsibilities Support and conduct GCP, GLP, and GVP audits as a lead auditor for assigned audits or as a team member, including internal processes, investigator sites, internal and external GLP study audits 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....