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
Benefits- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Free Food & Snacks
- Wellness Resources
- Stock Option Plan
At Frontier, we strive to build a diverse and equitable workplace. The salary range for this role is $200,000 - $275,000. Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.
This compensation and benefits information is based on Frontier's knowledge as of the date of publication, and may be modified in the future.
