Remote Pharma Product Complaints Investigator

Sumitomo Pharma; Madison (WI); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a PV Quality Assurance specialist to lead the intake, assessment, investigation, documentation, and closure of product complaints for commercial and clinical products, ensuring regulatory compliance and patient safety.

You will collaborate with Pharmacovigilance, Manufacturing and QA, maintain inspection-ready records, coordinate sample handling, and draft response communications while upholding cGMP.

Qualifications

• Bachelor's degree in a related field required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical.
• Working knowledge of cGMP requirements.
• Experience with product complaints and investigations.
• Experience with eQMS and QA systems.

Responsibilities

• Manage the intake, assessment, documentation, investigation, and closure of product complaints for commercial and clinical products in accordance with applicable regulations and company procedures.
• Receive, evaluate, and process product complaints, including identification and forwarding of potential adverse event, lack-of-effect, and product quality reports to appropriate functions.
• Conduct and coordinate complaint investigations with internal and external stakeholders to obtain information necessary to support complaint evaluations and product quality assessments.
• Ensure complaint records are complete, accurate, well-written, fact-based, and maintained in a state of inspection readiness.
• Draft and issue complaint response communications as required.
• Maintain compliance with cGMP requirements, regulatory expectations, and internal quality procedures.

Skills

FDA regulations

Pharmacovigilance

Investigation skills

Communication skills

Education

Bachelor's degree

Tools

eQMS

Quality databases

Job description

Sumitomo Pharma America, Inc. is seeking a PV Quality Assurance specialist to lead the intake, assessment, investigation, documentation, and closure of product complaints for commercial and clinical products, ensuring regulatory compliance and patient safety.

You will collaborate with Pharmacovigilance, Manufacturing and QA, maintain inspection-ready records, coordinate sample handling, and draft response communications while upholding cGMP.