🛠 Tech Stack

💼 About This Role

You'll lead the global Quality Management System (QMS) for a late-stage oncology company developing novel targeted therapies. Your work will directly impact inspection readiness and regulatory compliance across international markets.

🎯 What You'll Do

• Lead global QMS strategy and harmonization across regions
• Oversee document control, GxP training, and quality events
• Partner with global teams to integrate local regulatory requirements
• Ensure inspection readiness and support health authority inspections

📋 Requirements

• 10+ years in pharmaceutical/biotech quality
• Experience leading a global QMS across multiple regions
• Deep knowledge of global GxP regulations (FDA, EMA, PMDA)
• Proven ability to influence senior stakeholders on quality strategy

✨ Nice to Have

• Experience building or transforming global QMS in a growing organization
• Prior interaction with FDA, EMA, PMDA health authorities
• Experience supporting commercial product launches

🎁 Benefits & Perks

• 💵 Competitive cash compensation
• 📈 Robust equity awards
• 🏥 Strong benefits
• 📚 Learning and development opportunities

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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

[email protected]