💼 About This Role

You'll lead GCP quality and compliance engagements for virtual and emerging biotechs, ensuring clinical programs are inspection-ready. You'll drive sponsor oversight strategy and serve as the embedded clinical quality voice across Phase 1-3 trials. This role offers direct client-facing accountability without people management.

🎯 What You'll Do

• Establish and execute sponsor oversight programs for clinical trials
• Author quality agreements and review vendor documentation
• Plan, conduct, and report GCP audits
• Lead pre-approval inspection readiness and mock inspections

📋 Requirements

• GCP quality and compliance experience in clinical development
• Auditing investigator sites and clinical vendor systems
• Knowledge of FDA, EMA, and ICH GCP regulations
• Independent client-facing accountability in a consulting role

✨ Nice to Have

• CRO oversight experience
• Phase 1-3 clinical trial experience
• Quality agreement negotiation experience

🎁 Benefits & Perks

• 🏖️ Unlimited PTO

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Phone Screen· 30 min
2. 2Technical Interview· 60 min
3. 3Client Presentation· 60 min