Sr. Specialist, QA Systems

Role: Quality Assurance Specialist within a GxP-regulated biopharma environment, focusing on reinforcing quality systems and compliance activities to support neurobiological disorder treatments. Responsibilities: independently manage complex QA activities such as document control, vendor audits, investigations, change control, CAPA, and deviations; support electronic systems, review controlled documents, coordinate inspections, and generate performance reports; lead process improvements and mentor junior staff; analyze quality data for trend identification. Requirements: Bachelor's degree with 4+ years or Master's with 2+ years in pharma/biotech QA, including GxP processes; strong understanding of regulatory standards (FDA, ICH, GMP, GCP, GLP); proficiency with electronic QMS/LMS; excellent communication, organization, and problem-solving skills; ability to work independently and collaboratively. HighValue: GxP compliance, quality systems, audits, investigations, electronic systems, process improvement, regulatory standards, biotech/pharma industry experience, supporting inspections. WorkSetup: not specified; likely office-based or hybrid based on typical industry practices.