Electronic Quality Systems Health & Performance Management
Eli Lilly and Company
9 days ago
Remote friendly (Indianapolis, IN)
United States
Operations
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.
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, and change success rates to drive “right first time” metrics.
- Measure recurrence, cycle time, effectiveness checks, and lead systemic improvement programs.
- Provide management review inputs and drive executive reviews related to quality system health.
- Show proof of proactive quality checks.
- Produce timely, accurate, and inspection-defensible QMS performance reporting.
- Support risk-based prioritization across QMS with other ESE pillar leads.
- Maintain and run data integrity health signals and quality culture indicators.
- Drive continuous improvement through data-driven insights.
- Partner with tech to own the QMS data model, AI, and advanced analytics for quality signals.
Minimum Requirements:
- 10+ years’ pharmaceutical industry experience across Quality, Regulatory Affairs, Operations, or R&D.
- Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science 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.
Additional Skills/Preferences:
- Demonstrated influential leadership 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, and change success rates to drive “right first time” metrics.
- Measure recurrence, cycle time, effectiveness checks, and lead systemic improvement programs.
- Provide management review inputs and drive executive reviews related to quality system health.
- Show proof of proactive quality checks.
- Produce timely, accurate, and inspection-defensible QMS performance reporting.
- Support risk-based prioritization across QMS with other ESE pillar leads.
- Maintain and run data integrity health signals and quality culture indicators.
- Drive continuous improvement through data-driven insights.
- Partner with tech to own the QMS data model, AI, and advanced analytics for quality signals.
Minimum Requirements:
- 10+ years’ pharmaceutical industry experience across Quality, Regulatory Affairs, Operations, or R&D.
- Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science 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.
Additional Skills/Preferences:
- Demonstrated influential leadership and experience engaging with senior-level leaders in industry or health authorities.