Senior Quality Associate - Preclinical & Laboratory Quality
Core
Ensure compliance with GLP, GCLP, ISO/IEC 17025, and other quality requirements for preclinical and laboratory operations across R&D activities.
Role type
Senior Quality Associate (Preclinical & Laboratory QA)
Builds
Quality systems, compliance frameworks, and inspection readiness for R&D and laboratory functions
Domain
Life Sciences / Biotherapeutics / Preclinical Research
Required skills
GLP/GCLP/GxP knowledge, ISO/IEC 17025 understanding, quality system implementation, regulatory inspection support, deviation/CAPA management, risk assessment, assay method review, equipment validation review
Preferred skills
Stakeholder management, continuous improvement, problem-solving, decision-making
Technologies
None explicitly stated
Responsibilities
Support implementation and maintenance of quality systems and compliance processes; Partner with R&D to establish quality procedures; Review and approve study plans, protocols, reports, and documentation; Conduct quality inspections (facility, study, process, document, ISO 17025); Support internal and external regulatory inspections; Manage deviations, change controls, and CAPAs; Assess quality risks; Review assay method development and equipment validation documentation; Support key quality metrics and reporting
Seniority
Senior, hands-on IC
