Product Quality Complaints Manager

US-Remote

Full time

R01556

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 Linked In.

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.

• 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, lack-of-effect, and product quality reports to appropriate functions.

• Conduct and coordinate complaint investigations with internal and external stakeholders to obtain information necessary to support complaint evaluations and product quality assessments.

• Ensure complaint records are complete, accurate, well-written, fact-based, and maintained in a state of inspection readiness.

• Manage follow-up activities with consumers, healthcare professionals, pharmacies, distributors, and other external contacts as necessary to obtain complaint information and supporting documentation.

• Coordinate product sample return activities, sample tracking, laboratory testing requests, and related complaint documentation.

• Draft and issue complaint response communications as required.

• Maintain compliance with cGMP requirements, regulatory expectations, and internal quality procedures.

• Review and approve product complaint records, investigations, assessments, customer communications, and closure documentation to ensure completeness, accuracy, compliance, and adherence to company procedures.

• Exercise independent judgment in evaluating complaint information, determining investigation requirements, assessing product quality impact, and recommending appropriate disposition and closure activities.

• Strong knowledge of FDA, global GMP, pharmacovigilance, and product complaint regulations and guidance.

• Demonstrated experience managing pharmaceutical, biotechnology, medical device, and/or combination-product complaint processes.

• Excellent investigation, root cause analysis, problem-solving, and risk assessment skills.

• Experience utilizing electronic quality management systems (eQMS) and complaint management databases.

• Strong written and verbal communication skills, with the ability to communicate effectively across all levels of the organization.

• Ability to effectively prioritize multiple competing activities in a fast-paced, highly regulated environment.

• Strong attention to detail and commitment to data integrity and documentation quality.

• Bachelor’s degree in a related field required.

• Solid experience with product complaints, investigations, quality…