Remote Pharma Product Quality Complaints Specialist

Sumitomo Pharma; Denver (CO); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking an experienced Quality Assurance professional focused on pharmacovigilance and product complaints. The role ensures compliant intake, assessment, investigation, documentation, and closure of complaints for commercial and clinical products.

You will collaborate with PV, Manufacturing, QA, and external partners to support patient safety and regulatory compliance. The ideal candidate has strong FDA/GMP knowledge, extensive complaint investigations

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.

Responsibilities

• Manage intake, assessment, documentation, investigation and closure of product complaints per regulations and SOPs.
• Receive and process complaints, identify adverse events and product quality signals for escalation.
• Coordinate investigations with internal/external stakeholders to support quality assessments.
• Maintain complete, accurate complaint records and inspection-ready documentation.
• Communicate with consumers, healthcare professionals, pharmacies and distributors to gather information.

Skills

FDA GMP knowledge

Pharmacovigilance experience

Complaint investigations

eQMS experience

Strong communication

Education

Bachelor's degree

Tools

eQMS software

Job description

Sumitomo Pharma America, Inc. is seeking an experienced Quality Assurance professional focused on pharmacovigilance and product complaints. The role ensures compliant intake, assessment, investigation, documentation, and closure of complaints for commercial and clinical products.

You will collaborate with PV, Manufacturing, QA, and external partners to support patient safety and regulatory compliance. The ideal candidate has strong FDA/GMP knowledge, extensive complaint investigations