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 Excellence 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 enterprise 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 enterprise.
- reputed company advanced analytics to improve inspection readiness and compliance outcomes.
- Drive master data harmonization and governance reputed company with eQMS and enterprise 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 enterprise-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 enterprise-level transformation initiatives.
- Strong experience with data analytics, dashboards, and KPI development.
- Demonstrated success 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 & vision 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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