🛠 Tech Stack

💼 About This Role

You'll lead the global Quality Management System transition from clinical-stage to commercial-ready operations. Your work will ensure sustained inspection readiness and scalable compliance frameworks for a late-stage biopharmaceutical company. This role offers high visibility and strategic impact in a growing organization.

🎯 What You'll Do

• Optimize core QMS processes for commercial-stage operations
• Scale GxP training program with role-based curricula
• Lead validation of GxP computerized systems
• Build risk-based supplier quality management program

📋 Requirements

• BS/MS degree in a scientific discipline
• 10-15 years in pharmaceutical/biotech industry with 5+ years in leadership
• Deep understanding of GxP and Quality System requirements (US and EU)
• Experience designing and scaling Quality Management Systems

✨ Nice to Have

• Hands-on experience with Veeva Vault
• Experience with digital quality systems (eQMS, LMS)
• Proactive and decisive leadership style

🎁 Benefits & Perks

• 🏖️ Flexible hybrid work model
• 🏥 Comprehensive health insurance
• 💰 Competitive compensation package
• 📈 Professional development opportunities
• 🏢 Cambridge, MA location with dynamic team

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Call· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Tech/Behavioral Interview· 60 min