Senior Quality Associate
Core
Front-line quality partner supporting GMP/GxP oversight across clinical development, manufacture, and quality systems for investigational medicinal products.
Role type
Senior Quality Associate (GMP/GxP)
Builds
Clinical trial manufacturing outputs and compliant quality systems
Domain
Biotherapeutics / Clinical Development / GMP Manufacturing
Required skills
GMP/GxP knowledge, deviation management, investigation management, CAPA management, change control management, complaint handling, self-inspection, quality risk assessment, technical documentation review, GxP training
Preferred skills
Clinical trial GMP manufacturing experience, complex issue resolution, cross-functional influence
Technologies
GMP, GxP, QMS, QRAs
Responsibilities
Provide quality leadership to project teams; Manage deviations, OOS investigations, and CAPAs; Facilitate change controls and panels; Manage product technical complaints; Conduct self-inspections; Review and approve technical documentation; Support Quality Risk Assessments; Provide GxP training; Establish Quality Agreements; Support continuous improvement.
Seniority
Senior, hands-on IC