Remote Product Quality & Complaints Specialist

Sumitomo Pharma; Topeka (KS); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America is seeking a PV Quality Assurance professional to manage product complaint intake, investigation and closure in accordance with regulatory requirements. The role collaborates with Pharmacovigilance, Manufacturing and QA to ensure patient safety and compliance.

The candidate will oversee investigations, ensure complete documentation, and maintain inspection readiness while working primarily remotely with periodic on-site meetings.

Qualifications

• Bachelor's degree in a related field.
• Minimum 4 years of biotech/pharma experience with product complaints and quality systems.
• Working knowledge of cGMP and quality management systems.
• Experience managing product complaints, investigations and regulatory compliance.
• Ability to communicate clearly and work independently in a fast-paced environment.

Responsibilities

• Manage intake, assessment, documentation, investigation and closure of product complaints.
• Evaluate and forward adverse events and product quality reports to the right functions.
• Coordinate investigations with internal/external stakeholders to gather information.
• Ensure records are complete, accurate and inspection-ready.
• Maintain complaint documentation and respond to customers as required.
• Adhere to cGMP requirements and internal procedures.
• Review and approve records, communications, and closure documentation.

Skills

FDA compliance

GMP knowledge

Investigation skills

eQMS experience

Communication skills

Documentation

Risk assessment

Education

Bachelor's degree in a related field

Tools

eQMS

Job description

Sumitomo Pharma America is seeking a PV Quality Assurance professional to manage product complaint intake, investigation and closure in accordance with regulatory requirements. The role collaborates with Pharmacovigilance, Manufacturing and QA to ensure patient safety and compliance.

The candidate will oversee investigations, ensure complete documentation, and maintain inspection readiness while working primarily remotely with periodic on-site meetings.