Quality System Manager - Remote
Core
Direct efforts to harmonize quality practices across global JAX locations, drive organizational change, and implement quality improvements to enhance process efficiency and risk mitigation.
Role type
Senior Quality System Manager (Strategy & Operations)
Builds
Global quality systems, risk mitigation strategies, and a unified quality culture across domestic and international sites.
Domain
Biomedical research / Pharmaceutical Quality Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (Quality Systems)
Required skills
Risk management (Design FMEA, Process FMEA), Root Cause Analysis (RCA), statistical analysis, ISO 9001 standards, Computer System Validation, Quality by Design (QbD), Lean/Six Sigma, Change management, Functional management/leadership
Preferred skills
Lean/Six Sigma Certification, Quality certifications (CQA, CQM/OE), Regulatory compliance experience
Technologies
Quality and regulatory compliance software systems
Responsibilities
Develop long-term process development and improvement strategy; Proactively identify and analyze quality data to manage risk; Implement continuous quality improvements; Propagate quality assurance policy organization-wide; Co-lead implementation of quality software systems; Direct and coach quality personnel.
Seniority
Senior, hands-on IC with supervisory experience
