💼 About This Role

You'll lead the Quality function at a biotech startup pioneering precision medicine for immunological disorders. You'll shape the QMS, oversee GMP/GCP compliance, and partner with cross-functional teams to ensure regulatory success.

🎯 What You'll Do

• Lead Quality organization including GxP systems and QA oversight.
• Define quality vision and strategy tailored to company stage.
• Serve as primary contact for GMP, GCP, and GLP matters.
• Maintain phase-appropriate QMS including SOPs and vendor oversight.

📋 Requirements

• 12+ years Quality experience in biotech.
• Bachelor's degree in scientific or engineering discipline.
• Deep understanding of global GxP regulations (FDA, EMA, ICH).
• Proven leadership in building and scaling quality systems.

✨ Nice to Have

• Experience with biologics or advanced therapies.
• Experience managing QMS platforms and regulatory inspections.