Remote Product Quality Complaints Specialist

Sumitomo Pharma; Bismarck (ND); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America is seeking a PV Quality Assurance professional to manage the intake, assessment, investigation, documentation and closure of product complaints in compliance with regulatory requirements and company procedures. This role collaborates with PV, Manufacturing, QA and external partners to safeguard product quality and patient safety.

Primarily remote with periodic on-site meetings, domestic and international travel as needed.

Qualifications

• Bachelor’s degree in a related field.
• Solid experience with product complaints, investigations, quality systems, and regulatory compliance activities.
• Working knowledge of cGMP requirements and quality management systems.
• 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 per regulations and procedures.
• Receive, evaluate, and process product complaints, including potential AE and product quality reports.
• Coordinate complaint investigations with internal and external stakeholders.
• Ensure complaint records are complete, accurate, and inspection-ready.
• Follow up with consumers, healthcare professionals, pharmacies, distributors to obtain information and documentation.
• Coordinate product sample return, tracking, and testing requests.
• Draft and issue complaint communications as required.
• Maintain compliance with cGMP and regulatory expectations.
• Review and approve records, investigations, and closure documentation for completeness and compliance.
• Exercise independent judgment in evaluating information and determining investigation requirements.

Skills

FDA GMP knowledge

Investigations

eQMS experience

Documentation

Communication

Prioritization

Education

Bachelor’s degree in related field

Tools

eQMS

Complaint databases

Job description

Sumitomo Pharma America is seeking a PV Quality Assurance professional to manage the intake, assessment, investigation, documentation and closure of product complaints in compliance with regulatory requirements and company procedures. This role collaborates with PV, Manufacturing, QA and external partners to safeguard product quality and patient safety.

Primarily remote with periodic on-site meetings, domestic and international travel as needed.