Remote Product Quality & Complaints Lead

Sumitomo Pharma; Juneau (AK); À distance; USD 112 000 - 140 000; Plein temps

Résumé du poste

Sumitomo Pharma America, a leader in biopharma, seeks a Quality Assurance specialist focused on product complaints. The role ensures intake, assessment, investigation and closure of complaints in compliance with FDA, GMP, and company procedures. Collaboration with PV, Manufacturing, and QA is essential.

The position requires strong investigative, risk assessment, and documentation skills, with remote work options and periodic on-site meetings. Travel may be domestic and international as needed.

Qualifications

• Bachelor’s degree required.
• Minimum 4 years of relevant biotech/pharma experience.
• Minimum 3 years of product complaint experience.
• Experience with cGMP and quality systems.

Responsabilités

• Manage intake, assessment, documentation, investigation and closure of product complaints.
• Receive, evaluate and process product complaints and forward related reports.
• Coordinate investigations with internal/external stakeholders.
• Ensure records are complete, accurate and inspection-ready.
• Manage follow-up with consumers, HCPs, pharmacies and distributors.
• Coordinate sample return, tracking and testing requests.
• Draft and issue complaint response communications.
• Maintain compliance with cGMP and internal procedures.
• Review and approve records and closure documentation.

Connaissances

FDA GMP knowledge

Pharmacovigilance

Complaint investigations

eQMS experience

Documentation quality

Written and verbal communication

Prioritization skills

Data integrity

Formation

Bachelor’s degree in a related field

Outils

eQMS

Complaint management databases

Description du poste

Sumitomo Pharma America, a leader in biopharma, seeks a Quality Assurance specialist focused on product complaints. The role ensures intake, assessment, investigation and closure of complaints in compliance with FDA, GMP, and company procedures. Collaboration with PV, Manufacturing, and QA is essential.

The position requires strong investigative, risk assessment, and documentation skills, with remote work options and periodic on-site meetings. Travel may be domestic and international as needed.