Site Quality Manager- Injectables

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 DoAs 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 BringBachelor's or Master's in Life Sciences, Pharmacy, Chemistry, or related field.10-15+ years in pharmaceutical quality, with expertise in sterile injectable manufacturingExperience standing up quality systems in a greenfield or startup environment.Proven success in FDA inspections and PAI readiness.Strong knowledge of GMP, aseptic processing, Annex 1, and risk management.Leadership skills to build culture, teams, and systems from the ground up.?? Why Join Us?Be a founding quality leader at a cutting-edge, sterile injectable facility.Shape systems, teams, and culture with full executive and corporate backing.Drive innovations that impact patient safety and modern hospital care.Work in a dynamic, fast-paced environment with startup energy and long-term vision.

Created: 2025-10-02