Director of QA – Small Molecule (GCP/GMP) & QMS Lead

Frontier Medicines Corporation; Boston (MA); On-site; USD 200,000 - 275,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan (401k, IRA)

Life Insurance (Basic, Voluntary &

Paid Time Off (Vacation, Sick &

Family Leave (Maternity, Paternity)

Short Term & Long Term Disability

Training & Development

Free Food & Snacks

Wellness Resources

Stock Option Plan

Job summary

Frontier Medicines Corporation is seeking a Director/Sr. Director, Quality Assurance to lead and scale our QMS as our small molecule pipeline advances from Phase 1/2 toward global registration.

You will own GCP compliance across global clinical trials, provide phase-appropriate GMP oversight for API and drug product programs, and build an inspection readiness roadmap with CMC and external partners. Ideal candidates bring dual GCP/GMP expertise and a hands-on yet strategic mindset for a lean,

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Biochemistry or related field.
• 8+ years of QA experience in pharma/biotech, with 3+ years in leadership in a clinical-stage setting.
• Direct QA management for small molecule drug development, including CMC/GMP oversight.
• Strong knowledge of ICH GCP guidelines and phase-appropriate GMP regulations.
• Familiarity with US FDA and EU/EMA/PMDA/NMPA regulatory frameworks is advantageous.
• Experience implementing or managing modern eQMS systems (Veeva/TrackWise/KMS).
• Proven ability to thrive in a lean, fast-paced biotech environment with hybrid hands-on/leadership style.
• Excellent communication and stakeholder management; legally authorized to work in the United States.

Responsibilities

• Establish, maintain, and oversee the global GCP compliance strategy for Phase 1–2 trials and upcoming registrational studies.
• Lead qualification, selection, and auditing of CROs, trial sites, labs, and vendors across US, EU, and Asia.
• Design and execute annual risk-based GCP audit plans including site, vendor, and internal process audits.
• Review and approve critical clinical documents such as protocols, ICFs, and CSRs.
• Provide QA oversight of CMOs handling small molecule API synthesis, solid-state formulation, packaging, and labeling.
• Oversee disposition of clinical trial material batches to ensure compliance with global standards.
• Negotiate and maintain Quality Agreements with CMOs and material suppliers.
• Collaborate with CMC to investigate deviations and CAPAs as processes scale toward registration.
• Maintain and improve the eQMS to scale from early clinical phases to commercial readiness.
• Lead investigations into quality issues and root-cause analyses; ensure timely CAPAs.
• Prepare corporate inspection readiness roadmap for FDA, EMA, and other agencies; act as QA host during inspections.

Skills

QA leadership

GCP/GMP expertise

Small molecule

Regulatory knowledge (FDA/EU/EMA/PMDA/

eQMS (Veeva/TrackWise)

Root cause analysis & CAPA

Stakeholder management

US work authorization

Education

Bachelor’s degree in Chemistry/Pharmacy/Biochemistry

Tools

Veeva Vault Quality

ZenQMS

TrackWise

Job description

Frontier Medicines Corporation is seeking a Director/Sr. Director, Quality Assurance to lead and scale our QMS as our small molecule pipeline advances from Phase 1/2 toward global registration.

You will own GCP compliance across global clinical trials, provide phase-appropriate GMP oversight for API and drug product programs, and build an inspection readiness roadmap with CMC and external partners. Ideal candidates bring dual GCP/GMP expertise and a hands-on yet strategic mindset for a lean,