Electronic Quality Systems Health & Performance Management
Eli Lilly and Company
6 hours ago
Remote friendly (Indianapolis, IN)
United States
Operations
Overview
- 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 (working alongside with GPOs).
- 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 to drive systemic effectiveness and quality culture.
- Drive continuous improvement through data-driven insights.
- Partner with tech in owning QMS data model, AI, and advanced analytics for quality signals.
Minimum Requirements
- 10+ years’ experience in the pharmaceutical industry across Quality, Regulatory Affairs, Operations, or R&D.
- Bachelor’s degree in Natural Science, Engineering, Pharmacy, 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.
Additional Skills/Preferences
- Demonstrated influential leadership expertise and experience engaging with senior-level leaders in industry or health authorities.
- 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 (working alongside with GPOs).
- 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 to drive systemic effectiveness and quality culture.
- Drive continuous improvement through data-driven insights.
- Partner with tech in owning QMS data model, AI, and advanced analytics for quality signals.
Minimum Requirements
- 10+ years’ experience in the pharmaceutical industry across Quality, Regulatory Affairs, Operations, or R&D.
- Bachelor’s degree in Natural Science, Engineering, Pharmacy, 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.
Additional Skills/Preferences
- Demonstrated influential leadership expertise and experience engaging with senior-level leaders in industry or health authorities.