Electronic Quality Systems Health & Performance Management

Eli Lilly and Company • Indianapolis, IN

2d

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Quality Systems Health & Performance Management Leader is accountable for establishing and leading the enterprise capability for continuous monitoring, trending, and risk-based oversight of Quality Management Systems (QMS). This role provides objective, data-driven insight into the health, performance, and compliance posture of global quality systems and enables proactive management action before issues surface through audits or inspections. They will provide strategic quality oversight and expertise for the global Quality Systems, Overview: The electronic Quality Systems Health and Performance Management is responsible to: Define and operate the enterprise QMS health and performance framework. Define, monitor, and trend quality system KPIs, KQIs and risk indicators. Aggregate and trend Deviations, CAPA effectiveness, Complaints, Audit outcomes, change success rates to drive “right first time “metrics working alongside with GPOs Measure recurrence, cycle time, effectiveness checks & lead systemic improvement programs Provide management review inputs & drive executive reviews related to quality system health. Show proof of proactive quality checks. Timely, accurate, and inspection-defensible QMS performance reporting Support risk-based prioritization across QMS working with the other ESE pillar leads Maintain and run data integrity health signals, quality culture indicators to drive systemic effectiveness & quality culture Drive continuous improvement through data-driven insights. Partner with tech in owning QMS data model, AI & Advanced Analytics for quality signals

Requirements

• 10+ years’ experience in the pharmaceutical industry in roles across Quality, Regulatory Affairs, Operations or R&D)
• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field or Information Technology/Computer Systems.
• Demonstrated experience with enterprise QMS platforms and regulated quality processes
• Proven experience defining, trending, and interpreting quality system metrics
• Experience supporting regulatory inspections and audits related to quality system oversight
• Prior people leadership experience in a matrixed, global organization

Nice To Haves

• Demonstrated influential leadership expertise and experience engaging with senior-level leaders in industry or health authorities.

Responsibilities

• Define and operate the enterprise QMS health and performance framework.
• Define, monitor, and trend quality system KPIs, KQIs and risk indicators.
• Aggregate and trend Deviations, CAPA effectiveness, Complaints, Audit outcomes, change success rates to drive “right first time “metrics working alongside with GPOs
• Measure recurrence, cycle time, effectiveness checks & lead systemic improvement programs
• Provide management review inputs & drive executive reviews related to quality system health.
• Show proof of proactive quality checks.
• Timely, accurate, and inspection-defensible QMS performance reporting
• Support risk-based prioritization across QMS working with the other ESE pillar leads
• Maintain and run data integrity health signals, quality culture indicators to drive systemic effectiveness & quality culture
• Drive continuous improvement through data-driven insights.
• Partner with tech in owning QMS data model, AI & Advanced Analytics for quality signals

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees