💼 About This Role

You'll lead QA oversight of contract manufacturing and batch disposition activities for commercial vaccine products. You'll drive resolution of quality issues and champion a culture of quality excellence. This role offers the opportunity to shape quality systems at a clinical-stage vaccine innovation company.

🎯 What You'll Do

• Provide QA oversight of Contract Manufacturing Organizations.
• Lead batch disposition activities including review of executed batch records.
• Approve documentation such as deviations, change controls, and CAPAs.
• Lead deviation and product complaint investigations.

📋 Requirements

• Bachelor's degree in Chemistry, Biology, Pharmacy, or Engineering.
• 8+ years QA experience in pharmaceutical or biotech industry.
• Strong knowledge of cGMP and FDA/EMA regulations.
• Experience in clinical and commercial parenteral drug product.

✨ Nice to Have

• Knowledge of Risk Management principles.
• Experience in aseptic manufacturing (biologics) operations.
• Management and process improvement skills.

🎁 Benefits & Perks

• 🏖️ Competitive compensation including equity component
• 🏥 Comprehensive benefits package
• 📍 Hybrid work in San Carlos, CA