Remote Product Quality & Complaints Manager

Sumitomo Pharma America; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Sumitomo Pharma Co., Ltd. seeks a Senior QA professional to manage intake, assessment, investigation, and closure of product complaints for both commercial and clinical products.

You will work closely with Pharmacovigilance, Manufacturing, and Quality Assurance to ensure regulatory compliance and patient safety. The role requires strong knowledge of FDA/GMP regulations, experience with eQMS systems, and the ability to communicate findings clearly to stakeholders.

Qualifications

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

Responsibilities

• Oversee intake, assessment, investigation, documentation, and closure of product complaints for commercial and clinical products.
• Evaluate and route potential adverse events and product quality reports to appropriate functions.
• Coordinate investigations with internal and external stakeholders; maintain inspection-ready records.
• Draft complaint response communications and ensure compliance with regulatory requirements.
• Maintain confidentiality and ensure data integrity in all complaint records.

Skills

FDA/GMP knowledge

Investigation skills

eQMS experience

Root cause analysis

Communication skills

Prioritization

Data integrity

Education

Bachelor's degree in a related field

Job description

Sumitomo Pharma Co., Ltd. seeks a Senior QA professional to manage intake, assessment, investigation, and closure of product complaints for both commercial and clinical products.

You will work closely with Pharmacovigilance, Manufacturing, and Quality Assurance to ensure regulatory compliance and patient safety. The role requires strong knowledge of FDA/GMP regulations, experience with eQMS systems, and the ability to communicate findings clearly to stakeholders.