Quality System Manager - Farmington, CT - Hybrid
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
Builds
Global quality systems and compliance frameworks for a biomedical research institution
Domain
Biomedical research / Pharmaceutical quality systems
Deliverable
infrastructure
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
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 risks, implement continuous quality improvements, lead quality personnel through coaching and counseling, co-lead implementation of quality software systems
Seniority
Senior, hands-on IC with supervisory experience