Quality Engineer III - Product Quality Leader
Core
Quality owner for assigned biologics products and projects, ensuring regulatory compliance and final product disposition.
Role type
Product Quality Leader
Builds
Biologics portfolio products
Domain
Biopharmaceutical manufacturing (Biologics)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations knowledge, product release decision-making, investigation review, change control management, validation support, regulatory inspection support, continuous improvement
Preferred skills
Project-based or multi-client setting experience, academic background in biotechnology/biochemistry/microbiology/pharmacology
Technologies
GMP systems, validation tools
Responsibilities
Act as decision-maker for release and disposition of cell banks and bulk drug substance; Review and approve investigations, change controls, and relevant cGMP documentation; Support process, product, and testing validation activities; Lead quality aspects of complaints, recalls, change controls and deviations; Support regulatory inspections and customer audits; Drive continuous improvement of quality systems and ways of working
Seniority
Mid-Senior, hands-on IC
