Associate Director, CMC 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

Reporting to the Senior Director, CMC Quality Assurance, the Associate Director, CMC Quality Assurance is responsible for directing all quality related activities and process for product in clinical phase studies. This includes but not limited to supplier relationships/auditing, batch review/release, site transfers, and internal document set up/review, QMS, weekly team meetings for drug substance, drug product, packaging and labeling. In addition, you will be responsible for facilitating transition from drug development to commercial product. What You'll Do:

In this role, you'll have the opportunity to establish and maintain a risk-based and scientific-based quality system and decision-making approach. You will also:

• Audit the manufacturing facilities of vendors, customers and outside contract organizations.
• Facilitate and approve Quality Technical Agreements with vendors.
• Through a quality-system approach, ensure phase appropriate GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
• Apply phase appropriate GMP compliance principles to quality decisions.
• Lead investigations, CAPAs, deviations and quality events to resolution and closure.
• Transition phase 3 clinical stage material to commercial s...