Manager, Product Complaint

Role: Product Complaint Manager within Quality Assurance, GMP at Kiniksa Pharmaceuticals, focused on managing and ensuring compliance of product complaint handling for marketed and investigational biopharmaceutical products. Responsibilities: oversee complaint intake, investigation, evaluation, and documentation; communicate with stakeholders including patients, providers, and regulators; maintain compliance with global regulations (FDA, EU GMP, ICH); develop and improve SOPs; initiate CAPAs; coordinate cross-functional escalation and reporting; interact with auditors and deliver training; reconcile complaint data with safety teams; track metrics and report to senior management. Qualifications: BS in a scientific field; 5+ years GMP biopharma experience; strong knowledge of GMP regulations (21 CFR 210/211, ICH, FDA guidance); experience with aseptic manufacturing, labeling, and distribution processes; excellent written/verbal communication and attention to detail; proficiency in MS Office, familiarity with electronic systems like Veeva preferred. High-Value: GMP compliance, complaint investigation, biopharma quality systems, regulatory adherence, patient safety, international audit interaction. Work setup: onsite in Lexington, MA, five days/week.