💼 About This Role

You'll lead CMC Quality Assurance programs for a rare disease biopharmaceutical company, including Product Complaints, Annual Product Quality Review, and Change Control Review Board. You'll ensure GxP compliance and drive continuous improvement across manufacturing operations. This role offers the chance to impact life-changing treatments for rare disease patients.

🎯 What You'll Do

• Facilitate Global Annual Product Review with Quality Leads and Tech Ops.
• Manage Change Control Review Board and coach Change Owners.
• Support release of production lots per Ultragenyx procedures.
• Lead continuous improvement initiatives for CMC QA processes.

📋 Requirements

• Bachelor's degree or equivalent in QA or related discipline.
• 8+ years in GMP biopharmaceutical manufacturing quality or technical operations.
• Change Control process and Review Board management experience.
• Product Disposition experience.

✨ Nice to Have

• Product Complaint handling, investigations, and reporting.
• Knowledge of EMA, ANVISA, MHRA regulations.

🎁 Benefits & Perks

• 🏖️ Generous vacation and public holidays.
• 📈 Long term incentive and Employee stock purchase plans.
• 💪 Employee wellbeing benefits.
• 🏋️ Fitness reimbursement.
• 📚 Tuition sponsoring and professional development plans.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Technical Interview· 60 min
4. 4Panel Interview· 90 min
5. 5Offer· 30 min