💼 About This Role

You'll oversee GMP production operations for a clinical-stage biotech developing engineered organs. Your core impact includes ensuring compliance with cGMP standards and supporting manufacturing activities. This role is highly visible with cross-functional interaction.

🎯 What You'll Do

• Develop and implement QA oversight for clinical drug product manufacturing.
• Review and approve batch records, change controls, deviations, and CAPAs.
• Support qualification activities for systems, utilities, and equipment.
• Participate in cross-functional teams to resolve quality issues.
• Maintain QA Operations in state of compliance and inspection readiness.

📋 Requirements

• B.S./M.S. in Life Sciences or related field with 5+ years experience.
• Experience in GMP Quality Assurance for clinical biologics products.
• Knowledge of FDA/EMA/ICH regulations for clinical production.
• Ability to provide QA oversight to manufacturing operations.

✨ Nice to Have

• Experience with electronic systems compliant with 21 CFR Part 11.
• Supplier qualification audit experience.
• Organizational and staff mentorship skills.

🎁 Benefits & Perks

• 🏥 Health insurance
• 💰 Competitive compensation
• 📈 Career development opportunities