Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.
Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.
About the Role:
Reporting to the Associate Director, QO Americas-Compliance, the Senior Quality Engineer, Quality Assurance will play a key role in making decisions and executing QA and Regulatory Compliance activities for Insmed. In coordination with Associate Director, specific areas of responsibility include: GMP Product Release process, Drug, Device and Combination Product complaint investigations, QA-GMP Metrics (Management Review) monitoring, Annual Product Quality Reports, Supplier Interface, support change controls, among other QA related activities.
Additional representative responsibilities will include, but not necessarily be limited to, the following: