
The Associate Director, GMP QA Operations role serves as a key leader within the Quality organization at Kiniksa Pharmaceuticals, overseeing hands-on quality activities for GMP manufacturing across clinical programs. Key responsibilities include managing quality oversight for internal early-phase manufacturing and external CDMO operations, supporting technical transfer activities from development to commercial stages, and ensuring compliance with global regulatory standards through batch review, deviation management, and inspection readiness. The position appeals to candidates seeking to impact patient lives by advancing novel therapies for cardiovascular and inflammatory diseases within a collaborative, patient-first culture. This onsite role is based in Lexington, MA, requiring daily presence at the office with occasional travel for audits and inspections.








