- Location
- Boston, Massachusetts, United States · published
- Type
- Full-time
- Department
- IT
- Seniority
- Director
- Source
- Workable
Description
What’s in it for you?
Frontier Medicines is seeking a Director/Sr. Director, Quality Assurance to lead and scale our Quality Management System (QMS) as our small molecule pipeline advances from Phase 1/2 toward global registration over the next 2–3 years. This role will hold ultimate accountability for Good Clinical Practice (GCP) compliance across our global clinical trials while providing phase-appropriate Good Manufacturing Practice (GMP) oversight for our drug substance (API) and drug product programs.
Working in close partnership with Clinical Operations, CMC, and external partners, the Director will build the inspection readiness roadmap that bridges early-stage trials and commercial marketing authorization. The ideal candidate brings dual GCP/GMP expertise, deep small molecule experience, and a hands-on yet strategic mindset suited to a lean, fast-moving biotech environment.