Remote Product Quality Complaints Lead

Sumitomo Pharma; Helena (MT); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, Inc. in the United States is seeking a Product Complaints QA Specialist. The role reports to the Senior Director, PV Quality Assurance and supports the intake, assessment, investigation, documentation, and closure of product complaints in compliance with regulatory requirements.

Primarily remote, with periodic on-site meetings and travel domestically and internationally as needed. Requires a bachelor’s degree and at least 4 years in biotech/pharmaceuticals, strong

Qualifications

• Bachelor’s degree required.
• Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities required.
• Working knowledge of cGMP requirements and quality management systems required.
• Minimum 4 years of relevant experience in biotech or pharmaceutical industry, Bachelor’s Degree or equivalent years of work experience.
• Minimum 3 years of product complaint experience required.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints.
• Receive, evaluate, and process complaints incl. adverse event and product quality reports.
• Coordinate complaint investigations with internal and external stakeholders.
• Ensure records are complete, accurate, and inspection-ready.
• Manage follow-up with consumers, healthcare professionals, pharmacies, distributors, and other contacts.
• Coordinate product sample return activities, sample tracking, testing requests, and related documentation.
• Draft and issue complaint response communications.
• Maintain compliance with cGMP requirements and internal procedures.
• Review and approve complaint records, investigations, assessments, closure documentation.
• Exercise independent judgment in evaluating complaint information and determining disposition.

Skills

FDA regulations

GMP compliance

Pharmacovigilance

Product complaints

Investigation & root cause

eQMS

Communication skills

Education

Bachelor's degree in related field

Tools

eQMS

Complaint databases

Job description

Sumitomo Pharma America, Inc. in the United States is seeking a Product Complaints QA Specialist. The role reports to the Senior Director, PV Quality Assurance and supports the intake, assessment, investigation, documentation, and closure of product complaints in compliance with regulatory requirements.

Primarily remote, with periodic on-site meetings and travel domestically and internationally as needed. Requires a bachelor’s degree and at least 4 years in biotech/pharmaceuticals, strong