Associate Director / Director - Global Medicines Quality Organization
Eli Lilly and Company
8 hours ago
Remote friendly (Indianapolis, IN)
United States
Operations
Purpose
- Maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s).
- Provide strategic input, focus on results, think critically, and emphasize team collaboration.
- Lead GMQO associates supporting execution and delivery of submissions to global health authorities.
Primary Responsibilities
Leadership and Resource Management
- Accountable for recruitment, development, and retention of a diverse, capable workforce.
- Ensure training plans and timely completion of required training for direct reports.
- Talent identification and career development using 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 expertise.
- Drive innovation and model inclusivity.
- Coach and mentor staff in work procedures, Safety and Efficacy Quality System (SEQS), and issue resolution.
Quality System Implementation
- Facilitate quality reviews/consultations; deviation and change management; quality planning; CAPA implementation; quality assessments; quality issue resolution.
- Conduct quality assessments to monitor clinical development quality.
- Monitor/report metrics; partner with the business on quality initiatives.
- Represent the organization internally/externally in clinical development, regulatory, or safety quality.
Audits and Inspections
- Facilitate/deliver audits, regulatory inspections, and regulatory responses.
- Ensure ongoing inspection readiness.
- Escalate issues affecting clinical development, portfolio delivery, and business priorities.
Project Management and Process Improvement
- Identify/drive SEQS development and implementation projects.
- Support/lead global process improvement initiatives.
- Share learnings and best practices within the business area and across GMQO.
Minimum Qualifications
- Bachelor’s degree (preferably health/scientific).
- Experience in clinical development.
- Strong knowledge of GCP guidelines/regulations.
- Supervisory experience.
- Experience working globally.
- Strong leadership and self-management.
- Strong verbal and written communication.
- Problem solving and critical thinking.
Additional Preference
- Demonstrated project management experience.
Application/Other
- Indianapolis-based; at least 3 days/week on-site at Lilly Corporate Center.
- Maintain, develop, and improve quality system compliance and enhance quality by partnering with assigned portfolio/function(s).
- Provide strategic input, focus on results, think critically, and emphasize team collaboration.
- Lead GMQO associates supporting execution and delivery of submissions to global health authorities.
Primary Responsibilities
Leadership and Resource Management
- Accountable for recruitment, development, and retention of a diverse, capable workforce.
- Ensure training plans and timely completion of required training for direct reports.
- Talent identification and career development using 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 expertise.
- Drive innovation and model inclusivity.
- Coach and mentor staff in work procedures, Safety and Efficacy Quality System (SEQS), and issue resolution.
Quality System Implementation
- Facilitate quality reviews/consultations; deviation and change management; quality planning; CAPA implementation; quality assessments; quality issue resolution.
- Conduct quality assessments to monitor clinical development quality.
- Monitor/report metrics; partner with the business on quality initiatives.
- Represent the organization internally/externally in clinical development, regulatory, or safety quality.
Audits and Inspections
- Facilitate/deliver audits, regulatory inspections, and regulatory responses.
- Ensure ongoing inspection readiness.
- Escalate issues affecting clinical development, portfolio delivery, and business priorities.
Project Management and Process Improvement
- Identify/drive SEQS development and implementation projects.
- Support/lead global process improvement initiatives.
- Share learnings and best practices within the business area and across GMQO.
Minimum Qualifications
- Bachelor’s degree (preferably health/scientific).
- Experience in clinical development.
- Strong knowledge of GCP guidelines/regulations.
- Supervisory experience.
- Experience working globally.
- Strong leadership and self-management.
- Strong verbal and written communication.
- Problem solving and critical thinking.
Additional Preference
- Demonstrated project management experience.
Application/Other
- Indianapolis-based; at least 3 days/week on-site at Lilly Corporate Center.