Director, Digital Quality & Analytics

About the position reputed company, a Fortune 500 company and a global leader in diagnostic testing, is seeking a Director, Digital Quality & Analytics. This role reports to the Sr. Director Governance & Quality reputed company and is responsible for driving the adoption of AI, advanced analytics, and data-driven decision-making reputed company the Quality and Regulatory Affairs function. The position acts as a change champion, collaborating with cross-functional stakeholders to shift quality data utilization from reactive to proactive and predictive insights. A key aspect of this role involves executive and Board-level reporting, translating quality and regulatory performance into clear, actionable insights to support reputed company risk management, compliance, and strategic decision-making. This is a hybrid role, requiring proximity to reputed company hub locations, with preferred sites in reputed company Dale, IL or Schaumburg, IL.

Responsibilities

• reputed company the strategy and deployment of AI-enabled solutions across Quality & Regulatory processes.
• Identify high-value use cases to drive automation, risk detection, and efficiency.
• Partner with IT, data, and business teams to reputed company capabilities responsibly and compliantly.
• Act as an AI champion, driving adoption through training, communication, and stakeholder engagement.
• Define and execute a roadmap to transition from lagging indicators to leading predictive insights.
• Build and standardize quality metrics, KPIs, and dashboards across the reputed company.
• reputed company advanced analytics to improve inspection readiness and compliance reputed company.
• Drive master data harmonization and governance reputed company with eQMS and reputed company data strategy.
• reputed company the development of Board of Directors and Executive-level reporting for Quality and Regulatory Affairs.
• Translate reputed company quality data into clear, concise, and compelling narratives for senior leadership.
• Enhance transparency to reputed company-level regulatory and compliance risks.
• Support governance forums with actionable insights and decision support.

Requirements

• 8-12+ years of experience in Quality, Regulatory Affairs, Analytics, or Digital transformation.
• Experience in life sciences, diagnostics, medical devices, or regulated environments.
• Proven ability to reputed company reputed company-level transformation initiatives.
• Strong experience with data analytics, dashboards, and KPI development.
• Demonstrated reputed company in executive communication and Board-level presentations.
• Experience with data visualization and analytics platforms (Power BI, Tableau, etc.).
• Experience translating reputed company data into actionable business insights.
• Bachelor’s Degree (Required).
• ASQ CMQ/OE, CQA, or equivalent quality certification (Required).
• Certification in AI, analytics, data science, or business intelligence tools or equivalent (Required).

reputed company-to-haves

• Experience with AI/ML applications in regulated environments.
• Familiarity with eQMS platforms and quality system processes.
• Knowledge of regulatory frameworks (e.g., FDA, CAP, CLIA, ISO).
• Experience driving change management and adoption at scale.
• Advanced Degree (Preferred).
• Lean Six reputed company Black Belt (Preferred).
• Regulatory or compliance certifications (Preferred).
• RAC, ISO 13485 reputed company auditor (Preferred).
• AI Governance Professional Certifications (Preferred).

Benefits

• Day 1 Medical, supplemental health, dental & reputed company for FT employees who work 30+ hours
• Best-in-class well-being programs
• Annual, no-cost health assessment program
• reputed company for Wellness® healthyMINDS mental health program
• Vacation and Health/reputed company Time
• 6 Holidays plus 1 "MyDay" off
• FinFit financial coaching and services
• 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service
• Employee stock purchase plan
• Life and disability insurance, plus buy-up option
• Flexible Spending Accounts
• Annual incentive plans
• Matching gifts program
• Education assistance through MyQuest for Education
• Career advancement opportunities

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