Assist with quality event management for internal and external early phase operations, including deviations, investigations, OOS/OOT results, root cause analysis, CAPA, effectiveness checks, and change control; escalate significant issues to the Director, Operational Quality. Review and approve internal and vendor generated documentation, including master batch records, executed batch records, clinical label text and labeling, specifications, certificates of analysis, qualification protocols and reports, stability data, and testing records.