Remote Pharma Product Quality & Complaints Lead

Sumitomo Pharma; Frankfort (KY); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking an experienced professional to manage the end-to-end handling of product complaints for commercial and clinical products.

You will coordinate investigations, ensure regulatory compliance, and maintain inspection-ready records while collaborating with Pharmacovigilance, Manufacturing, and QA teams. The role requires strong investigation skills, knowledge of FDA/GMP requirements, and experience with eQMS systems.

Qualifications

• Bachelor’s degree in a related field is required.
• Minimum 4 years of biotech/pharmaceutical experience in product complaints and quality systems.
• Minimum 3 years of product complaint experience.
• Working knowledge of cGMP and regulatory requirements.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints.
• Receive, evaluate, and process product complaints including adverse event signals.
• Coordinate investigations with internal/external stakeholders.
• Ensure records are inspection-ready.
• Manage follow-up with consumers, healthcare professionals, etc.
• Coordinate sample return, testing requests, and documentation.
• Draft and issue complaint responses.
• Maintain compliance with cGMP and regulatory expectations.
• Review and approve records and closure documentation.
• Exercise independent judgment in evaluation and disposition.

Skills

FDA GMP knowledge

Pharmacovigilance

Complaint investigations

eQMS

Regulatory compliance

Communication skills

Education

Bachelor's degree in a related field

Tools

eQMS software

Complaint databases

Job description

Sumitomo Pharma America, Inc. is seeking an experienced professional to manage the end-to-end handling of product complaints for commercial and clinical products.

You will coordinate investigations, ensure regulatory compliance, and maintain inspection-ready records while collaborating with Pharmacovigilance, Manufacturing, and QA teams. The role requires strong investigation skills, knowledge of FDA/GMP requirements, and experience with eQMS systems.