🛠 Tech Stack

💼 About This Role

You'll lead global product quality strategy for late-phase clinical and commercial programs at an oncology-focused organization. You will drive quality risk management and CMC regulatory compliance across R&D, manufacturing, and regulatory functions. This role combines strategic oversight with hands-on leadership in investigations and governance.

🎯 What You'll Do

• Lead global product quality strategy across late-phase clinical and commercial programs.
• Serve as SME in quality risk management, investigations, and change control.
• Represent quality organization in governance forums and cross-functional meetings.
• Manage Product Quality Network teams and oversee global stakeholder deliverables.
• Drive quality performance monitoring, trend analysis, and continuous improvement.

📋 Requirements

• Bachelor's degree with 8+ years in quality sciences or regulated industry (pharma/biotech).
• 5+ years of managerial or leadership experience managing teams or programs.
• Expertise in quality systems and regulatory frameworks (FDA, EMA).
• Proven experience leading investigations and implementing quality risk management (ICH Q9).

✨ Nice to Have

• Master's degree preferred with 10+ years experience.
• Proficiency in statistical tools like Minitab, JMP, Tableau, or SciLab.
• Experience developing training programs and building SME networks.

🎁 Benefits & Perks

• 💰 Competitive salary $172k-$232k with annual bonus and equity.
• 🏥 Comprehensive benefits including medical, dental, vision, life insurance.
• 🏖️ Paid time off and flexible leave policies.
• 📈 401(k) retirement plan with FSA/HSA options.
• 🌍 Global career development with training and leadership programs.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Panel Interview· 60 min
4. 4Offer· 1 week