Remote Product Quality & Compliance Manager

Sumitomo Pharma; Salt Lake City (UT); Remote; USD 112,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

Sumitomo Pharma America, Inc. is seeking a qualified individual for the Quality department to manage product complaints from intake to closure, ensuring regulatory compliance and patient safety. The role collaborates with Pharmacovigilance, Manufacturing and external partners.

You will review records, coordinate investigations, and draft communications while maintaining inspection readiness and data integrity in a fast-paced, regulated environment.

Qualifications

• Bachelor’s degree in a related field.
• 4+ years of biotech or pharmaceutical experience.
• 3+ years in product complaints or similar quality roles.
• Working knowledge of cGMP and quality systems.

Responsibilities

• Manage intake, assessment, documentation, investigation and closure of product complaints.
• Process complaints, identify adverse events and forward to relevant functions.
• Coordinate investigations with internal and external stakeholders; maintain inspection readiness.
• Ensure records are complete, accurate and well-documented.
• Oversee sample handling, testing requests and related documentation.
• Draft complaint communications and ensure regulatory compliance.

Skills

FDA knowledge

GMP knowledge

Investigation

Root cause analysis

Communication

eQMS

Documentation

Risk assessment

Education

Bachelor's degree

Tools

eQMS software

Job description

Sumitomo Pharma America, Inc. is seeking a qualified individual for the Quality department to manage product complaints from intake to closure, ensuring regulatory compliance and patient safety. The role collaborates with Pharmacovigilance, Manufacturing and external partners.

You will review records, coordinate investigations, and draft communications while maintaining inspection readiness and data integrity in a fast-paced, regulated environment.