Remote Product Quality Complaints Specialist

Sumitomo Pharma; Providence (RI); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking an experienced Quality Assurance professional to manage the intake, assessment, and closure of product complaints for commercial and clinical products. You will work with Pharmacovigilance, Manufacturing, and QA to ensure patient safety and regulatory compliance.

The role requires a Bachelor’s degree, at least 4 years in biotech/pharma, strong investigation and documentation skills, and the ability to operate in a fast‑paced, regulated environment.

Qualifications

• Bachelor’s degree in a related field required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry.
• Minimum 3 years of product complaint experience required.
• Working knowledge of cGMP requirements and quality management systems required.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints per regulations.
• Receive, evaluate, and process product complaints with potential adverse events and quality reports.
• Coordinate investigations with internal and external stakeholders.
• Maintain compliant complaint records and ensure inspection readiness.
• Draft and issue complaint responses as required.

Skills

FDA regulations

GMP compliance

Pharmacovigilance

Complaint management

Investigation & root cause

Education

Bachelor’s degree in a related field

Tools

eQMS

Complaint databases

Job description

Sumitomo Pharma America (SMPA) is seeking an experienced Quality Assurance professional to manage the intake, assessment, and closure of product complaints for commercial and clinical products. You will work with Pharmacovigilance, Manufacturing, and QA to ensure patient safety and regulatory compliance.

The role requires a Bachelor’s degree, at least 4 years in biotech/pharma, strong investigation and documentation skills, and the ability to operate in a fast‑paced, regulated environment.