Director/Sr. Director, Quality Assurance (GCP/GMP)
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.
Requirements
What will you be doing?
- Establish, maintain, and oversee the global GCP compliance strategy for Phase 1–2 clinical trials, and prepare quality systems for upcoming registrational studies
- Lead the qualification, selection, and routine auditing of CROs, clinical trial sites, central labs, and bioanalytical vendors across the US, EU, and Asia
- Design and execute the annual risk-based GCP audit plan, including investigator site, vendor, and internal process audits
- Review and appr
