Senior Associate, Quality Assurance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: This position is in charge of GQP/QMS operations for Japan marketed products, which handle Product Complaints from initiation to close-out, both for medicinal product and medical device, full documentation to support Japan market release, documentation of changes, deviations & CAPAs as needed to support products in Japan. What You'll Do: Ensure accurate and thorough complaint intake information, replacement need, troubleshooting with complainant, complainant follow-ups, product complaint investigations, tracking and trending of complaint data. Accurate reporting into the internal software system/QMS system, follow-up, communication to complainants, identification of trends, assisting with determining CAPA’s Review each complaint assigned for accurate/missing information, complaint details, further regulatory compliance actions, replacement needs, or unreported adverse events. Act as technical product subject matter expert and trouble shoot complaints with complainants Contact complainants for complaint follow up information, trouble shooting, and medical device replacement and returns Perform complaint investigations to determine root cause, identify resolution and respond to the complainants Issue complaint close-out notifications to complainants. Ensure Adverse Events reported through the complaint system or at patient follow-up are reported within one business day Ensure the reconciliation between the complaints report and Safety/Customer reports Support product/supplier changes, deviations and CAPAs, assisting with technical write up, impact assessment, and root cause analysis. Assist in maintaining the applicable GQP and QMS SOPs. Check quality progress on a monthly basis as they relate to batch release, complaints, deviations, CAPAs’, change requests or other relevant quality metrics. Asist internal process audits and external supplier audits as necessary. Actively work on Global and local Quality projects Support 3 officer activities and authority inspection Who You Are: Minimum 3 years’ experience in a similar role within pharmaceutical or medical device industry Thorough knowledge of GMP, GQP and good documentation practice Experience in quality related complaint handling is preferred Experience in working with an electronic Quality Management system is desired. Must have excellent communication skills (verbal and written). Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter. Highly organized with a strong attention to detail, clarity, accuracy and conciseness. Works effectively across functions as a team player Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). An uncompromising ethical standard and level of conduct are essential Bachelor’s degree in life sciences or equivalent through experience Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect and Integrity; along with any other position specific competencies Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace Non-smoker Travel up to 10% (domestic and international), some of which will be overnight in nature Life at Insmed インスメッド日本オフィスは、国会議事堂を望む東京の中心部、溜池山王駅直結の好立地に位置しています。最新のワークスタイ ... (truncated, view full listing at source)