Remote Product Quality Complaints Specialist

Sumitomo Pharma; Columbus (OH); Remote; USD 112,000 - 140,000; Full time

Benefits offered by this job

401(k) plan

Medical/dental/vision

Paid time off

Job summary

Sumitomo Pharma America, Inc. is seeking a PV Quality Assurance professional to own 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. The role emphasizes independent judgment, adherence to cGMP, and precise documentation in a primarily remote setting with occasional on-site meetings.

Qualifications

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

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints.
• Evaluate and forward adverse event reports to appropriate functions.
• Coordinate investigations with internal and external stakeholders.
• Ensure complaint records are complete, accurate, and inspection-ready.
• Oversee follow-up with consumers, healthcare professionals, pharmacies, distributors.
• Draft complaint response communications as required.
• Maintain compliance with cGMP and regulatory expectations.

Skills

FDA regulations

GMP knowledge

Pharmacovigilance

Complaint management

Investigation skills

eQMS usage

Written communication

Time management

Education

Bachelor's degree in a related field

Tools

eQMS

Job description

Sumitomo Pharma America, Inc. is seeking a PV Quality Assurance professional to own 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. The role emphasizes independent judgment, adherence to cGMP, and precise documentation in a primarily remote setting with occasional on-site meetings.