Associate Director / Director - Global Medicines Quality Organization
Eli Lilly and Company
2 hours ago
On-site
Indianapolis, IN
Operations
Purpose
- Maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s).
- Lead GMQO associates supporting execution and delivery of submissions to global health authorities.
- Provide leadership and resource management for quality system implementation, audit and inspection readiness, quality project management, and process improvement.
Primary Responsibilities
Leadership and Resource Management
- Recruit, develop, and retain a diverse, highly capable workforce.
- Ensure individual training plans and timely completion of required training for direct reports.
- Drive talent identification and career development using an end-to-end mindset and judgement-based decisions.
- Ensure GMQO associate competencies are present and continuously improving.
- Manage workload based on portfolio prioritization, regional requirements, and individual expertise.
- Foster innovation and model inclusivity.
- Coach and mentor staff on work procedures, the Safety and Efficacy Quality System (SEQS), and issue resolution.
Quality System Implementation
- Support/define/facilitate quality reviews and consultations.
- Lead deviation and change management, quality planning, CAPA implementation, quality assessments, and quality issue resolution within scope.
- Ensure quality assessments monitor clinical development quality in the business area.
- Monitor and report quality metrics to business management.
- Partner with the business on quality initiatives.
- Represent Lilly internally and externally in clinical development, regulatory, or safety quality.
Audits and Inspections
- Facilitate and/or deliver audits, regulatory inspections, and regulatory responses.
- Ensure ongoing inspection readiness.
- Escalate issues impacting clinical development, portfolio delivery, and business priorities; recommend follow-up actions.
Project Management and Process Improvement
- Identify and/or drive projects to develop and implement SEQS.
- Support and/or lead global process improvement initiatives.
- Share learnings and communicate best practices within the business area and across Global Medicines Quality Organization.
Minimum Qualification Requirements
- Bachelor’s degree (preferably health-related or scientific).
- Experience in clinical development.
- Strong knowledge of GCP guidelines and regulations within scope.
- Supervisory experience.
- Experience working in a global environment.
- Strong leadership and self-management skills.
- Strong verbal and written communication skills.
- Demonstrated problem solving and critical thinking.
Other Information/Additional Preferences
- Demonstrated project management experience.
Location/Schedule
- Indianapolis-based; at least 3 days per week on-site at Lilly Corporate Center.
- Maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s).
- Lead GMQO associates supporting execution and delivery of submissions to global health authorities.
- Provide leadership and resource management for quality system implementation, audit and inspection readiness, quality project management, and process improvement.
Primary Responsibilities
Leadership and Resource Management
- Recruit, develop, and retain a diverse, highly capable workforce.
- Ensure individual training plans and timely completion of required training for direct reports.
- Drive talent identification and career development using an end-to-end mindset and judgement-based decisions.
- Ensure GMQO associate competencies are present and continuously improving.
- Manage workload based on portfolio prioritization, regional requirements, and individual expertise.
- Foster innovation and model inclusivity.
- Coach and mentor staff on work procedures, the Safety and Efficacy Quality System (SEQS), and issue resolution.
Quality System Implementation
- Support/define/facilitate quality reviews and consultations.
- Lead deviation and change management, quality planning, CAPA implementation, quality assessments, and quality issue resolution within scope.
- Ensure quality assessments monitor clinical development quality in the business area.
- Monitor and report quality metrics to business management.
- Partner with the business on quality initiatives.
- Represent Lilly internally and externally in clinical development, regulatory, or safety quality.
Audits and Inspections
- Facilitate and/or deliver audits, regulatory inspections, and regulatory responses.
- Ensure ongoing inspection readiness.
- Escalate issues impacting clinical development, portfolio delivery, and business priorities; recommend follow-up actions.
Project Management and Process Improvement
- Identify and/or drive projects to develop and implement SEQS.
- Support and/or lead global process improvement initiatives.
- Share learnings and communicate best practices within the business area and across Global Medicines Quality Organization.
Minimum Qualification Requirements
- Bachelor’s degree (preferably health-related or scientific).
- Experience in clinical development.
- Strong knowledge of GCP guidelines and regulations within scope.
- Supervisory experience.
- Experience working in a global environment.
- Strong leadership and self-management skills.
- Strong verbal and written communication skills.
- Demonstrated problem solving and critical thinking.
Other Information/Additional Preferences
- Demonstrated project management experience.
Location/Schedule
- Indianapolis-based; at least 3 days per week on-site at Lilly Corporate Center.