Remote Product Quality & Complaints Manager

Sumitomo Pharma; Jackson (MS); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, a global pharmaceutical company, seeks a Senior PV Quality Assurance professional for its US operations. The role ensures compliant management of product complaints, coordinating with Pharmacovigilance, Manufacturing and QA to support patient safety and regulatory compliance.

Responsibilities include intake, investigations, documentation, and closure of complaints, maintaining inspection readiness, and issuing communications.

Qualifications

• Bachelor’s degree in a related field required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry.
• Minimum 3 years of product complaint experience required.
• 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 potential adverse events and product quality reports.
• Coordinate complaint investigations with internal and external stakeholders to obtain necessary information.
• Ensure complaint records are complete, accurate, well-written, and inspection-ready.
• Manage follow-up activities with consumers, healthcare professionals, pharmacies, distributors, and other contacts.
• Coordinate product sample return activities, sample tracking, and related documentation.
• Draft and issue complaint response communications as required.
• Review and approve product complaint records and closure documentation for completeness and compliance.
• Apply independent judgment to determine investigation requirements and dispositions.

Skills

FDA regulations

GMP knowledge

Pharmacovigilance

Investigation

Communication skills

Education

Bachelor’s degree in related field

Tools

eQMS software

Complaint databases

Job description

Sumitomo Pharma America, a global pharmaceutical company, seeks a Senior PV Quality Assurance professional for its US operations. The role ensures compliant management of product complaints, coordinating with Pharmacovigilance, Manufacturing and QA to support patient safety and regulatory compliance.

Responsibilities include intake, investigations, documentation, and closure of complaints, maintaining inspection readiness, and issuing communications.