Manager, Product Complaint

Responsibilities

• Ensure all product complaints are received, reviewed, evaluated, and investigated in accordance with applicable procedures
• Manage complaint intake, triage, investigation, and closure within the electronic Quality Events system
• Communicate directly with patients, healthcare providers, and distributors to support investigations
• Maintain and execute complaint handling processes to ensure compliance with FDA, EU GMP, and ICH regulations
• Contribute to the development and continuous improvement of SOPs and work instructions
• Initiate and implement Corrective and Preventive Actions (CAPAs) based on complaint trends
• Coordinate cross-functional escalation with Quality, Manufacturing, Regulatory Affairs, and Medical Safety teams
• Interact with internal and external auditors and inspectors regarding complaint handling
• Perform monthly reconciliation of product complaints with Global Medical Safety
• Maintain accurate complaint metrics and provide status reports to Senior Management

Requirements

• Bachelor of Science degree in a scientific field (e.g., Biology, Chemistry)
• 5+ years of experience in a GMP biopharmaceutical setting
• Familiarity with GMP regulations, including 21 CFR 210 and 211, and ICH guidelines
• Understanding of drug product aseptic manufacturing, labeling, packaging, and distribution processes
• Experience leading and authoring product complaint investigations
• Proficiency with Microsoft Excel, Word, and PowerPoint
• Strong written and verbal communication skills
• High attention to detail and ability to prioritize in a fast-paced environment

Preferred Qualifications

• Experience with electronic document management systems such as Veeva

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.