Sr. Specialist, QA Systems

Summary

Sr. Specialist overseeing quality assurance systems, records management, and compliance in a pharmaceutical/biotech GxP-regulated environment. Responsibilities include managing electronic quality systems, processing controlled documents and SOPs, supporting inspections and audits, analyzing quality metrics and dashboards, leading process improvement initiatives, and mentoring junior staff. Requires a bachelor's degree with 4+ years of pharma/biotech QA experience (or master's with 2+), strong knowledge of FDA/ICH/GMP/GLP/GCP regulations, proficiency with QMS and LMS platforms, and demonstrated leadership and analytical capabilities.