Site Quality Manager- Injectables

Job Description

Join us in building a world-class sterile injectable manufacturing facility from the ground up.

We are a patient-centric, fast-growing pharmaceutical company focused on delivering specialty IV bag products that enhance hospital efficiency, reduce waste, and elevate patient care. Our new state-of-the-art site in Branchburg, NJ marks the launch of our sterile injectable manufacturing platform — and we’re looking for a Site Quality Manager to lead the charge in quality and compliance.

🔍 What You’ll Do

As our Site Quality Manager , you’ll play a critical leadership role in :

• Designing and implementing GMP-compliant Quality Management Systems (QMS) for a greenfield site.
• Driving inspection readiness and ensuring compliance with FDA, EMA, ICH, Annex 1, and cGxP standards.
• Leading batch release, deviation investigations, CAPA, change control, and complaint handling.
• Building and mentoring a high-performing quality team (QA, QC, Microbiology, Doc Control).
• Partnering cross-functionally to qualify equipment, validate processes, and launch commercial operations.
• Acting as the site’s primary quality authority during audits and regulatory inspections.

✅ What You Bring

💡 Why Join Us?