Global Clinical Manufacturing Qa Gmp
CurrentProvide QA leadership and oversight for small molecule product management. Implement, perform, and maintain Quality Systems and procedures, contributing to continuous improvement. Support the implementation and promotion of Incyte Quality Management Systems and Global Policies. Develop, implement, and maintain Incyte procedures for global clinical manufacturing Quality. Act as a Key User of internal eDMS/eQMS, offering advice and training as needed. Act as QA Representative for Business Reviews Program with CMOs, ensuring compliance and performance. Perform QA duties and provide oversight for supplier quality events in clinical development projects. Lead Quality Business Review Meetings with CMOs as the Incyte representative. Conduct internal and external cGMP audits, reviewing and approving auditee responses, and following up on CAPAs. Oversee suppliers' GMP compliance in accordance with Incyte’s procedures. Drive the resolution of major Quality issues. Review and approve internal and external deviations, OOS, OOT, and related investigations. Ensure implementation of internal and external change controls and CAPAs. Fulfill QA role in managing internal Quality Events records in Veeva, including audits, deviations, CAPAs, and change controls. Perform quality review of stability data for clinical stage products. Approve supplier GMP documents, including master batch records, specifications, and test procedures. Manage and organize batch disposition activities for assigned clinical products, deciding on product batch disposition. Review Regulatory documentation, such as INDs, NDAs, and IMPD, as well as responses to Health Authority questions. Collect, report, and maintain Quality Management System metrics associated with quality assurance. Manage and track controlled documents distribution to external CMOs, ensuring consistency with applicable regulatory files.
