Director, Quality Systems & Compliance

Responsibilities

• Lead and improve Quality Systems including Document Management, Training, CAPA, Deviations, and Risk Management
• Drive continuous inspection readiness and serve as the primary host for client audits and regulatory inspections
• Serve as Business System Owner for eQMS, DMS, and LMS, driving optimization through automation and AI
• Implement AI-enabled use cases for predictive quality signal detection and pattern recognition
• Act as the primary interface between Quality, IT, and Data/AI teams to translate business needs into digital solutions
• Lead the QMS Business System Governance process and participate in Digital Steering Committees
• Drive process simplification, standardization, and operational excellence

Requirements

• 12+ years of biopharmaceutical experience with leadership in Quality Systems and Compliance
• Demonstrated experience as a Business System Owner or Digital Process Owner in a GxP environment
• Strong expertise in global GxP regulations
• Experience with enterprise systems such as eQMS, DMS, LMS, SAP, LIMS, or MES
• Experience driving digital transformation, automation, and advanced analytics
• Familiarity with AI/ML tools and digital quality solutions in regulated environments
• Strong understanding of data integrity, CSV/CSA, and digital system compliance

Preferred Qualifications

• Experience with Veeva Vault

About the Company

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization through integrated technologies and manufacturing expertise.