Remote Product Quality Complaints Lead

Sumitomo Pharma; Santa Fe (NM); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America in the United States is seeking a Senior PV Quality Assurance professional to oversee the intake, assessment, investigation, and closure of product complaints for commercial and clinical products.

The role collaborates with Pharmacovigilance, Manufacturing, Quality Assurance, and external partners to ensure patient safety and regulatory compliance. This is a primarily remote position with periodic on-site meetings and travel.

Qualifications

• Bachelor’s degree required.
• Minimum 4 years of biotech or pharmaceutical industry experience.
• Minimum 3 years of product complaint experience.
• Working knowledge of cGMP requirements and quality management systems.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints.
• Evaluate and forward adverse event and product quality reports to appropriate functions.
• Coordinate investigations with internal and external stakeholders to support evaluations.
• Maintain complaint records for inspection readiness and regulatory compliance.

Skills

FDA GMP knowledge

PV QA experience

Investigation skills

eQMS usage

Documentation quality

Communication skills

Education

Bachelor's degree

Tools

eQMS software

Quality systems

Job description

Sumitomo Pharma America in the United States is seeking a Senior PV Quality Assurance professional to oversee the intake, assessment, investigation, and closure of product complaints for commercial and clinical products.

The role collaborates with Pharmacovigilance, Manufacturing, Quality Assurance, and external partners to ensure patient safety and regulatory compliance. This is a primarily remote position with periodic on-site meetings and travel.