💼 About This Role

You'll oversee quality-related activities for radiopharmaceutical manufacturing at our Angleton site, ensuring GxP compliance with ISO 13485 standards. You'll partner with operations to maintain regulatory alignment and support the international rollout of our approved prostate cancer imaging agent.

🎯 What You'll Do

• Provide quality oversight of production, QC, and supply chain activities
• Review batch records and quality control results for compliance
• Lead deviations, investigations, CAPA, change control, and complaint reports
• Manage FDA/regulatory interactions for site inspections

📋 Requirements

• Bachelor's degree in Life Sciences or related field
• 5+ years of experience in a quality assurance role
• Experience in GxP manufacturing operations
• Willingness to work with radioactive materials

✨ Nice to Have

• Experience with sterile manufacturing regulations
• Supplier/vendor assurance experience
• Cross-functional collaboration skills

🎁 Benefits & Perks

• 💰 Competitive salary and annual performance-based bonuses
• 📈 Equity-based incentive program
• 🏖️ Generous vacation and paid wellness days
• 📚 Support for learning and development