Hiring: Manager, Product Complaint Company: Kiniksa Pharmaceuticals Location: Lexington, MA Job Posted Time: 2026-09-13 11:46:14 Employment Type: On-site Target Skills & Keywords : Microsoft Excel, Microsoft PowerPoint About the job Experience: •Understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, combination products, 21 CFR part 4, ICH guidelines, FDA guidance documents •Understanding and familiarity with processes for drug product aseptic manufacturing, labeling/packaging, and distribution •A proactive, detailed oriented person, with experience in leading and authoring product complaint investigations, and the ability to clearly and accurately present information in writing •Demonstrated strong written and verbal communication skills •Proven mindset of proactive continuous improvement Required Skills: •Reporting to the Senior Director QA, Product Complaint Manager will support end-to-end product complaint management for Kiniksa’s marketed and investigational products. •This role is responsible for complaint intake, investigation coordination, complainant follow-up, quality metric reporting, and general QA Operations support while partnering with internal teams and external manufacturers, laboratories, device suppliers, and distribution partners to ensure timely, compliant, and inspection-ready complaint handling. Qualifications: •Requires a Bachelor of Science degree in scientific field (e.g., Biology, Chemistry) with 5+ years’ experience in a GMP biopharmaceutical setting Compensation: •$131,500 - $146,500 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!