Remote Product Quality & Complaints Lead

Sumitomo Pharma; Honolulu (HI); Remote; USD 112,000 - 140,000; Full time

Job summary

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

Responsibilities include coordinating investigations, ensuring inspection-ready records, and drafting responses.

Qualifications

• Bachelor’s degree required.
• 4+ years of biotech/pharmaceutical experience in complaints, investigations, and regulatory compliance.
• Working knowledge of cGMP and quality systems.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints per regulations.
• Receive and route complaints, including potential adverse events and product QA reports.
• Coordinate investigations with internal/external stakeholders to support quality assessments.
• Maintain complete, accurate, well-written records in inspection-ready state.
• Follow up with consumers, healthcare professionals, and distributors for information and documentation.
• Draft and issue complaint responses as required.

Skills

Pharmacovigilance

Complaint handling

GMP knowledge

Root cause analysis

eQMS

Documentation

Regulatory compliance

Education

Bachelor's degree

Tools

eQMS

Complaint management databases

Job description

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

Responsibilities include coordinating investigations, ensuring inspection-ready records, and drafting responses.