Global ESO Quality Specialist
Core
Ensuring product quality, regulatory compliance, and continuous improvement for sterile pharmaceutical products within the External Supplier Organization (ESO).
Role type
Quality Assurance Specialist (Sterile Products)
Builds
Sterile biological drugs, terminally sterilized products, and aseptically filled products for brands like Nemluvio and Sculptra
Domain
Pharmaceutical manufacturing / Sterile production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
complaint management, deviation management, change control, CAPA, risk management, aseptic processing oversight, environmental monitoring, cGMP compliance, ISO 13485/MDR regulatory knowledge, batch record review, SOP management, validation protocols
Preferred skills
Pharmacist degree, Master's in Life Sciences/Engineering, advanced problem-solving
Technologies
cGMP, FDA regulations, ISO 13485, MDR
Responsibilities
Manage complaint management processes, execute product release activities, provide QA oversight for sterile manufacturing, review quality documentation and validation protocols, ensure regulatory compliance with FDA/ISO/MDR, drive continuous improvement initiatives
Seniority
Mid-level (2–5 years experience)
