Remote Product Quality & Complaint Investigation Lead

Sumitomo Pharma; Nashville (TN); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a QA professional to manage product complaints from intake through closure, ensuring compliance with regulatory expectations.

The role collaborates with Pharmacovigilance, Manufacturing, and QA to support product quality and patient safety. Candidates should have a Bachelor’s degree and at least 4 years in biotech/pharma quality systems, with 3+ years specifically in product complaints investigations.

Qualifications

• Bachelor’s degree in a related field required.
• Minimum 4 years’ biotech/pharma experience in quality/compliance.
• 3+ years in product complaints investigations and cGMP.

Responsibilities

• Manage intake, assessment, documentation, investigation and closure of product complaints.
• Receive, evaluate and route complaints including potential adverse events to correct teams.
• Coordinate investigations with internal/external stakeholders.
• Ensure records are complete, accurate and inspection-ready.
• Manage follow-up with consumers, HCPs, pharmacies and distributors for information.
• Coordinate product sample returns, testing requests and documentation.
• Draft and issue complaint responses as required.
• Maintain compliance with cGMP and regulatory expectations.

Skills

FDA regulations

GMP knowledge

Pharmacovigilance

Investigation

Quality systems

Documentation

Education

Bachelor’s degree

Tools

eQMS

Complaint databases

Job description

Sumitomo Pharma America, Inc. is seeking a QA professional to manage product complaints from intake through closure, ensuring compliance with regulatory expectations.

The role collaborates with Pharmacovigilance, Manufacturing, and QA to support product quality and patient safety. Candidates should have a Bachelor’s degree and at least 4 years in biotech/pharma quality systems, with 3+ years specifically in product complaints investigations.