🛠 Tech Stack

💼 About This Role

You'll lead the global GMP QA strategy for a clinical-stage biotechnology company transitioning to commercial readiness. You'll build and scale a high-performing QA team while ensuring compliance with cGMP regulations. This role offers the chance to shape quality systems that enable speed and confident decision-making.

🎯 What You'll Do

• Build, lead, and scale a high-performing GMP QA team
• Develop and execute GMP QA functional strategy
• Oversee GMP QA systems including deviations and CAPAs
• Lead readiness for regulatory inspections and audits

📋 Requirements

• 15+ years of progressive GMP QA experience in pharma/biotech
• Proven track record leading GMP QA through clinical to commercial transition
• Experience with Veeva Quality Suite (QMS) implementation
• Leadership experience managing managers and senior professionals

✨ Nice to Have

• Experience in biologics or antibody programs
• Experience with FDA and EMA regulatory inspections

🎁 Benefits & Perks

• 💰 Competitive compensation with annual bonus
• 🏥 Comprehensive health benefits
• 📈 Stock options
• 🏖️ Flexible PTO
• ✈️ Travel opportunities (up to 25%)

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Panel Interview· 90 min