Remote Product Quality Complaints Manager

Sumitomo Pharma; Pierre (SD); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America (SMPA) is seeking a Senior PV Quality Assurance professional to lead the intake, investigation, and closure of product complaints for both commercial and clinical products. You will ensure records are complete, compliant, and audit-ready while collaborating with Pharmacovigilance, Manufacturing, and QA to safeguard patient safety and regulatory adherence.

Responsibilities include coordinating investigations, evaluating product quality impact, and drafting communications.

Qualifications

• Bachelor's degree in a related field required.
• Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities required.
• Working knowledge of cGMP requirements and quality management systems required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints for commercial and clinical products.
• Receive and process product complaints, including identification of potential adverse events and product quality reports.
• Coordinate investigations with internal and external stakeholders to support evaluations.
• Ensure complaint records are complete, accurate, and inspection-ready.
• Manage follow-up with consumers, healthcare professionals, pharmacies, and distributors to obtain information.
• Draft and issue complaint response communications as required.

Skills

PV Quality

FDA regs

Investigations

Quality systems

Education

Bachelor's Degree

Tools

eQMS

Complaint databases

Job description

Sumitomo Pharma America (SMPA) is seeking a Senior PV Quality Assurance professional to lead the intake, investigation, and closure of product complaints for both commercial and clinical products. You will ensure records are complete, compliant, and audit-ready while collaborating with Pharmacovigilance, Manufacturing, and QA to safeguard patient safety and regulatory adherence.

Responsibilities include coordinating investigations, evaluating product quality impact, and drafting communications.