Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

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.

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

• 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

• Bachelor’s degree in life sciences or equivalent through experience
• Native Japanese Speaker
• 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