Director, Global QA & GCP/GMP Strategy

RA Cap; Boston (MA); On-site; USD 200,000 - 275,000; Full time

Benefits offered by this job

Health care plan

401k/Retirement plan

Life Insurance

Paid time off

Job summary

Frontier Medicines seeks a Director/Sr. Director, Quality Assurance to lead the QMS as its small molecule pipeline advances toward registration.

You will own GCP compliance across global trials and provide phase-appropriate GMP oversight for API and drug product programs. In partnership with Clinical Operations, CMC and external partners, you will build an inspection readiness roadmap bridging trials and marketing authorization, balancing hands-on work with strategic leadership in a lean biotech

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Biochemistry or related field.
• 8+ years of QA experience in pharmaceutical/biotech, incl. 3+ years in leadership in a clinical-stage setting.
• Direct QA experience for small molecule drug development with CMC/GMP oversight.
• Strong knowledge of GCP and GMP; global regulatory familiarity (FDA, EMA, PMDA, NMPA).
• Experience implementing or managing modern eQMS such as Veeva Vault Quality, ZenQMS, TrackWise.

Responsibilities

• Establish, maintain, and oversee global GCP compliance for Phase 1-2 trials and prep for registrational studies.
• Lead qualification, selection, and auditing of CROs, sites, labs, and vendors across US, EU, and Asia.
• Design and execute annual risk-based GCP audit plan incl. site and vendor audits.
• Review critical documents: protocols, ICFs, CSRs; approve them.
• QA oversight of CMOs handling API synthesis, solid-state formulation, packaging, labeling.

Skills

QA leadership

GCP/GMP expertise

Regulatory knowledge

Vendor management

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry/Pharmacy/Biochemistry

Tools

Veeva Vault Quality

ZenQMS

TrackWise

Job description

Frontier Medicines seeks a Director/Sr. Director, Quality Assurance to lead the QMS as its small molecule pipeline advances toward registration.

You will own GCP compliance across global trials and provide phase-appropriate GMP oversight for API and drug product programs. In partnership with Clinical Operations, CMC and external partners, you will build an inspection readiness roadmap bridging trials and marketing authorization, balancing hands-on work with strategic leadership in a lean biotech