Remote Product Quality & Complaints Lead

Sumitomo Pharma America, Inc.; United States; À distance; USD 112 000 - 140 000; Plein temps

Résumé du poste

Sumitomo Pharma America, Inc. is seeking a Quality Assurance professional to manage the intake, assessment, and investigation of product complaints across commercial and clinical products.

You will work with Pharmacovigilance, Manufacturing, and external partners to ensure patient safety and regulatory compliance. The role requires strong knowledge of FDA and global GMP, robust investigation and root-cause skills, and experience with eQMS and complaint databases.

Qualifications

• Bachelor’s degree in a related field is required.
• Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities.
• Working knowledge of cGMP requirements and quality management systems.

Responsabilités

• Manage intake, assessment, documentation, investigation, and closure of product complaints in accordance with regulations and procedures.
• Receive, evaluate, and process product complaints, including forwarding potential adverse events and quality reports.
• Conduct and coordinate complaint investigations with internal and external stakeholders.
• Ensure complaint records are complete, accurate, and inspection-ready.
• Coordinate sample return, tracking, testing requests, and related documentation.
• Draft and issue complaint response communications as required.
• Maintain compliance with cGMP requirements and regulatory expectations.
• Review and approve records and closure documentation for completeness and compliance.
• Exercise independent judgment to determine investigation requirements and disposition.

Connaissances

FDA regulations

GMP knowledge

Pharmacovigilance

Investigation

Risk assessment

Documentation

Communication

Formation

Bachelor's degree

Outils

eQMS

Complaint databases

Description du poste

Sumitomo Pharma America, Inc. is seeking a Quality Assurance professional to manage the intake, assessment, and investigation of product complaints across commercial and clinical products.

You will work with Pharmacovigilance, Manufacturing, and external partners to ensure patient safety and regulatory compliance. The role requires strong knowledge of FDA and global GMP, robust investigation and root-cause skills, and experience with eQMS and complaint databases.