🛠 Tech Stack

💼 About This Role

You'll lead the Quality function for a high-growth clinical trial company, ensuring GCP compliance across US, UK, and EU trials. You'll oversee GCP auditing and inspection readiness while managing a small team. This role offers high impact in a mission-driven startup.

🎯 What You'll Do

• Lead GCP audit program design and execution
• Ensure inspection readiness for FDA and EMA
• Provide hands-on GCP auditing of trials and vendors
• Manage and develop the Quality team

📋 Requirements

• Significant hands-on experience in GCP quality assurance
• Strong working knowledge of ICH GCP (E6 R2/R3)
• Experience supporting regulatory inspections (FDA and EMA)
• Experience developing and maintaining a GCP quality management system

✨ Nice to Have

• Experience with eQMS platforms like Qualio
• Exposure to EU/UK clinical trial regulations
• Experience in a high-growth startup environment

🎁 Benefits & Perks

• 🎯 High-Impact Mission
• 🚀 Fast-Paced Growth & Ownership
• 🤝 Collaborative, No-Ego Culture
• 💼 Remote Work

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Technical/Leadership Interview· 60 min