Associate Director Quality Systems & Analytics

A growing, innovation-driven organization in a highly regulated industry is seeking an experienced Associate Director, Quality Systems & Analytics to lead the evolution of its Quality Management System (QMS) and enterprise quality analytics capabilities. This role is instrumental in transforming the QMS from a compliance-focused repository into a proactive, data-driven platform that enables intelligent decision-making, enterprise risk visibility, and operational agility.

The ideal candidate combines strong regulatory knowledge with systems expertise, analytics acumen, and leadership capability.

The Associate Director, Quality Systems & Performance is accountable for quality analytics, QMS system administration, enterprise risk management, quality management review meetings, and enterprise change control. This role evolves the QMS from a compliance repository to an intelligent, integrated system that enables proactive quality management, risk-based decision-making, and business agility.

Maintain and optimize QMS infrastructure, workflows, and configuration. Manage system utilization, liaising with IT and vendors. Champion adoption of new QMS tools through effective change management. Ensure system compliance, user access management, and platform enhancements.

Design and implement enterprise quality metrics framework with KPIs, targets, and benchmarks. Integrate quality data from multiple sources for holistic insights. Build self-service analytics infrastructure with real-time dashboards. Apply advanced analytics to identify patterns, predict risks, and generate actionable insights. Drive QMS technology innovation and automation.

Lead enterprise-wide quality risk management processes, including risk identification, assessment, and mitigation strategies. Develop and maintain risk registers and reporting frameworks. Partner with Quality Business Partners to embed risk-based thinking into quality processes.

Own and manage enterprise change control process. Ensure robust impact assessment, stakeholder alignment, and documentation for quality-impacting changes.

Lead and develop QMS team. Partner with business unit leaders to tailor QMS processes and metrics to business objectives. Lead Quality Management Review process and present comprehensive reports to leadership on QMS performance, trends, and improvements. Serve as subject matter expert for customer audits.

• Bachelor's degree in relevant field
• 5+ years' experience in GCP or GMP environment
• 3+ years people management experience
• Experience implementing or optimizing a Quality Management System (QMS)
• Strong experience in enterprise risk management and change control
• Knowledge of GCP, GMP, and regulatory guidelines (ICH, FDA)
• Strong analytical and data interpretation skills with ability to design metrics frameworks and create visualizations
• Excellent communication, project management, and change management abilities
• Flexibility to work outside standard business hours for global operations

• Experience with business intelligence tools (Tableau, Power BI)
• Continuous improvement methodologies (Lean, Six Sigma)
• ISO 9001 knowledge