Product Quality Complaints Manager

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. Job Overview: This position reports to the Senior Director, PV Quality Assurance and is part of the Quality department which is responsible for ensuring compliant management of product complaints associated with commercial and clinical products. The role is responsible for the intake, assessment, investigation, documentation, and closure of product complaints in accordance with applicable regulatory requirements and company procedures and works closely with Pharmacovigilance, Manufacturing, Quality Assurance, and external partners to support product quality, patient safety, and regulatory compliance. Essential Functions Required for Job Manage the intake, assessment, documentation, investigation, and closure of product complaints for commercial and clinical products in accordance with applicable regulations and company procedures Receive, evaluate, and process product complaints, including identification and forwarding of potential adverse event