Senior IT Quality Systems Analyst

Responsibilities

• Lead the selection, deployment, administration, and continuous improvement of computer-based systems for Manufacturing, Laboratory, and Quality Management
• Serve as the subject matter expert and system owner for LIMS and QMS solutions
• Perform operational support including troubleshooting, issue resolution, and performance optimization for GxP systems
• Lead system lifecycle management including configuration, upgrades, patching, and change management
• Architect and maintain system integrations and laboratory instrument connectivity
• Lead computer system validation (CSV) activities in accordance with FDA, EMA, and GAMP 5 standards
• Ensure compliance with 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles
• Support investigations, root cause analysis, CAPAs, and remediation activities

Requirements

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related discipline
• 8+ years of experience in biotech or pharmaceutical environments supporting Quality Systems, LIMS, or QMS
• Experience in GxP-regulated environments with knowledge of computer system validation and SDLC
• Strong knowledge of 21 CFR Part 11, Annex 11, and ALCOA+ principles
• Hands-on experience with LIMS and QMS platform configuration and administration
• Experience with laboratory instrument integration and enterprise system connectivity

Preferred Qualifications

• Experience with cell and gene therapy or pharmaceutical manufacturing
• Direct experience with LabVantage LIMS, MasterControl QMS, MES, or Blue Mountain CMMS
• Experience designing digital lab ecosystems integrated with ERP, ELN, or CDS
• Technical experience with SQL, scripting, or database management
• Relevant certifications in GxP or CSV

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells.