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Salary: USD 200,000 - 275,000 / annual
Frontier Medicines is seeking a Director of Quality Assurance to lead and scale the Quality Management System (QMS) as the company's small molecule pipeline advances from Phase 1/2 toward global registration over the next 2–3 years. This role holds ultimate accountability for Good Clinical Practice (GCP) compliance across global clinical trials while providing phase-appropriate Good Manufacturing Practice (GMP) oversight for drug substance (API) and drug product programs.
The Director will work in close partnership with Clinical Operations, Chemistry, Manufacturing & Controls (CMC), and external partners to build an inspection readiness roadmap that bridges early-stage trials and commercial marketing authorization.
Key Responsibilities:
- Establish, maintain, and oversee the global GCP compliance strategy for Phase 1–2 clinical trials and prepare quality systems for 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 annual risk-based GCP audit plans, 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, out-of-specification results, and stability data anomalies as processes scale
- Maintain and continuously improve the electronic QMS (eQMS) to scale from early clinical phases to commercial readiness
- Lead investigations into quality issues, deviations, and serious breaches, ensuring robust root-cause analysis and timely corrective and preventive actions (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
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:
- Bachelor's degree or higher in Chemistry, Pharmacy, Biochemistry, or related scientific discipline
- 8+ years of QA experience in 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 with EU/EMA and Asian regulatory frameworks (PMDA, NMPA) 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 requiring hybrid hands-on and high-level approach
- Strong communication and stakeholder management skills
- Legally authorized to work in the United States
