GMP)

Frontier Medicines•Boston, MA

About The Position

Frontier Medicines is seeking a Director/Sr. Director, Quality Assurance to lead and scale its Quality Management System (QMS) as its small molecule pipeline advances from Phase 1/2 toward global registration over the next 2–3 years. The role has ultimate accountability for Good Clinical Practice (GCP) compliance across global clinical trials and provides phase-appropriate Good Manufacturing Practice (GMP) oversight for drug substance (API) and drug product programs. Working closely with Clinical Operations, CMC, and external partners, the Director will build an inspection-readiness roadmap bridging early-stage trials and commercial marketing authorization. The role calls for dual GCP/GMP expertise, small molecule experience, and a hands-on yet strategic approach suited to a lean, fast-moving biotech environment.

Requirements

Bachelor’s degree or higher in Chemistry, Pharmacy, Biochemistry, or a related scientific discipline.
8+ years of QA experience in the pharmaceutical or biotech industry, including at least 3 years in a leadership or senior management role in a clinical-stage setting.
Direct experience managing QA for small molecule drug development, including CMC/GMP oversight of chemical synthesis, solid-state formulation, and stability testing.
Robust expertise in global ICH GCP guidelines and strong working knowledge of phase-appropriate GMP regulations.
Strong familiarity with US FDA frameworks.
Experience implementing or managing a modern eQMS.
Proven success in a lean, fast-paced biotech environment requiring a hybrid hands-on and high-level approach.
Strong communication and stakeholder management skills.
Legally authorized to work in the United States.

Nice To Haves

Experience with EU/EMA and Asian regulatory frameworks, such as PMDA and NMPA.
Experience with eQMS platforms such as Veeva Vault Quality, ZenQMS, or TrackWise.

Responsibilities

Establish, maintain, and oversee the global GCP compliance strategy for Phase 1–2 clinical trials and prepare quality systems for upcoming registrational studies.
Lead 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 approve critical clinical documents, including protocols, Investigator Brochures, Informed Consent Forms, and Clinical Study Reports.
Provide QA oversight of external CMOs handling small molecule API synthesis, solid-state formulation, packaging, and labeling.
Oversee review and phase-appropriate disposition of clinical trial material batches to ensure production meets global regulatory standards.
Negotiate, author, and maintain Quality Agreements with CMOs and critical raw material suppliers.
Partner with CMC to investigate manufacturing deviations, OOS results, and stability data anomalies as processes scale toward registration.
Maintain and continuously improve the eQMS so it scales from early clinical phases to commercial readiness.
Lead investigations into quality issues, deviations, and serious breaches, ensuring robust root-cause analysis and timely execution of CAPAs.
Author and execute a corporate inspection-readiness roadmap for FDA (BIMO), EMA, and Asian regulatory agency inspections.
Serve as primary QA host or back-room lead during inspections.