Remote Product Quality Complaints Manager

Sumitomo Pharma; Olympia (WA); Remote; USD 112.000 - 140.000; Vollzeit

Zusammenfassung

Sumitomo Pharma America is seeking a Quality Assurance professional to lead the intake, assessment, investigations, and closure of product complaints for commercial and clinical products. You will collaborate with Pharmacovigilance, Manufacturing, and QA to ensure compliant handling and documentation.

The role requires a bachelor’s degree, 4+ years in biotech/pharma, and strong knowledge of cGMP and quality systems.

Qualifikationen

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

Aufgaben

• Manage intake, assessment, documentation, investigation, and closure of product complaints in accordance with regulations and procedures.
• Receive, evaluate, and process product complaints including potential adverse events and product quality reports.

Kenntnisse

FDA GMP compliance

Pharmacovigilance

Investigations

eQMS

Communication

Ausbildung

Bachelor's degree in related field

Tools

eQMS software

Jobbeschreibung

Sumitomo Pharma America is seeking a Quality Assurance professional to lead the intake, assessment, investigations, and closure of product complaints for commercial and clinical products. You will collaborate with Pharmacovigilance, Manufacturing, and QA to ensure compliant handling and documentation.

The role requires a bachelor’s degree, 4+ years in biotech/pharma, and strong knowledge of cGMP and quality systems.