Pharma Product Quality Complaints Specialist

Sumitomo Pharma; Carson City (NV); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, Inc. in the United States is seeking a Quality Assurance professional to oversee product complaints from commercial and clinical products, ensuring regulatory compliance and patient safety.

The role reports to the Senior Director, PV Quality Assurance and collaborates with Pharmacovigilance, Manufacturing, and QA partners to drive complete investigations, well-documented records, and timely closures.

Primarily remote with periodic on-site meetings; travel may be required.

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, and closure of product complaints per regulations.
• Receive and process product complaints, including adverse event reports.
• Coordinate investigations with internal and external stakeholders.
• Ensure records are complete and inspection-ready.
• Maintain compliance with cGMP and quality procedures.

Skills

FDA GMP knowledge

Pharmacovigilance experience

Investigation & root cause analysis

eQMS experience

Communication skills

Education

Bachelor’s degree

Tools

eQMS software

Complaint management databases

Job description

Sumitomo Pharma America, Inc. in the United States is seeking a Quality Assurance professional to oversee product complaints from commercial and clinical products, ensuring regulatory compliance and patient safety.

The role reports to the Senior Director, PV Quality Assurance and collaborates with Pharmacovigilance, Manufacturing, and QA partners to drive complete investigations, well-documented records, and timely closures.

Primarily remote with periodic on-site meetings; travel may be required.