Remote Product Quality Complaints Specialist

Sumitomo Pharma; United States; Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America is seeking a Quality professional to manage intake, investigation, and closure of product complaints for commercial and clinical products. You will coordinate investigations with internal and external stakeholders to ensure complete, accurate records and regulatory compliance.

The role requires strong knowledge of FDA/gmp guidance, PV processes, and experience with eQMS and complaint databases. Travel for on-site support and audits may be necessary.

Qualifications

• Bachelor's degree in a related field; solid experience with product complaints, investigations, quality systems, and regulatory compliance.
• Minimum 4 years of biotech/pharma experience; minimum 3 years in product complaints.
• Working knowledge of cGMP requirements and quality management systems.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints for commercial and clinical products.
• Receive, evaluate, and process product complaints, including forwarding of potential adverse events to appropriate functions.
• Coordinate product sample return activities, testing requests, and related complaint documentation.
• Draft and issue complaint response communications.
• Maintain compliance with cGMP requirements and regulatory expectations.

Skills

Regulatory knowledge

Pharmacovigilance processes

Investigations & root cause analysis

eQMS experience

Written & verbal communication

Prioritization in regulated env

Data integrity & documentation

Education

Bachelors degree in related field

Tools

eQMS software

Complaint databases

Job description

Sumitomo Pharma America is seeking a Quality professional to manage intake, investigation, and closure of product complaints for commercial and clinical products. You will coordinate investigations with internal and external stakeholders to ensure complete, accurate records and regulatory compliance.

The role requires strong knowledge of FDA/gmp guidance, PV processes, and experience with eQMS and complaint databases. Travel for on-site support and audits may be necessary.