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 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, and serve as primary QA host or back-room lead during inspections
• Traits we believe make a strong candidate: 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 alongside strong working knowledge of phase-appropriate GMP regulations
• Strong familiarity with US FDA frameworks; experience with EU/EMA and Asian regulatory frameworks (e.g., PMDA, NMPA) is highly beneficial
• Experience implementing or managing a modern eQMS (e.g., Veeva Vault Quality, ZenQMS, TrackWise)
• Proven success in a lean, fast-paced biotech environment that calls for a hybrid hands-on and high-level approach
• Strong communication and stakeholder management skills
• Legally authorized to work in the United States