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Product Complaint Manager

Company

Katalyst HealthCares & Life Sciences

Location

Boston, United States

Type

Full-time


Job Description:
  • The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at our client.
  • This role will support quality activities associated within the Small Molecule, Biologics, Device CMC Compliance team and will partner with various internal and external cross-functional teams including Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations and external Call Centres.
  • Must have excellent communication.
  • Responsibilities:
  • Support activities associated with the product complaint process, including reconciliation, training, complaint sample management, triage, trending, SOP management, etc.
  • Process incoming clinical and commercial product complaints, including intake, initial evaluation and triage.
  • Conduct product complaint investigations and author investi...
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