Remote Pharma Product Complaints Lead

Sumitomo Pharma; Hartford (CT); Remote; USD 112,000 - 140,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking an experienced professional to lead quality assurance activities for product complaints.

You will manage intake, investigation, documentation, and closure, coordinating with PV, manufacturing, and QA to ensure patient safety and regulatory compliance. The role requires strong investigation, root cause and risk assessment skills, proficiency with eQMS, and the ability to communicate findings clearly across teams in a fast-paced, heavily regulated

Qualifications

• Bachelor’s degree in a related field 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 for commercial and clinical products.
• Receive, evaluate, and process product complaints; forward potential adverse events and product quality reports.
• Coordinate complaint investigations with internal and external stakeholders.
• Ensure complaint records are complete, accurate, and inspection-ready.
• Manage follow-up activities with consumers, healthcare professionals, pharmacies, distributors, and others.
• Coordinate product sample returns, testing requests, and related documentation.
• Draft and issue complaint response communications.
• Maintain compliance with cGMP, regulatory expectations, and internal procedures.
• Review and approve product complaint records and closure documentation.
• Exercise independent judgment in evaluating information and determining disposition.

Skills

FDA/GMP knowledge

Pharmacovigilance

Complaint investigations

Root cause analysis

Risk assessment

eQMS experience

Communication skills

Independent judgment

Education

Bachelor's degree

Tools

eQMS

Complaint management databases

Job description

Sumitomo Pharma America, Inc. is seeking an experienced professional to lead quality assurance activities for product complaints.

You will manage intake, investigation, documentation, and closure, coordinating with PV, manufacturing, and QA to ensure patient safety and regulatory compliance. The role requires strong investigation, root cause and risk assessment skills, proficiency with eQMS, and the ability to communicate findings clearly across teams in a fast-paced, heavily regulated