Global Quality & Regulatory Audit Director

Eli Lilly and Company; Indianapolis (IN); Vor Ort; USD 164.000 - 240.000; Vollzeit

Benefits dieser Stelle

Company bonus

Comprehensive benefits package

401(k) and pension

Zusammenfassung

Eli Lilly and Company, headquartered in Indianapolis, seeks a Sr. Director for Global Medical Regulatory Safety to lead the Global Quality Auditing program.

You will drive audits across Clinical Development, Regulatory, Safety/Pharmacovigilance, and Product Quality, partnering with global quality leadership to ensure compliance and strategic quality improvements. You will manage a global staff of auditors, set strategy, and balance resources with audit demands, while engaging with external

Qualifikationen

• Bachelor’s degree in a scientific or health-related field required.
• Minimum of five years in quality, clinical development, safety, or regulatory affairs.
• Prior line management experience.

Aufgaben

• Lead Global Quality Auditing (GQA) teams for audits across Clinical Development, safety, regulatory affairs and product quality.
• Provide strategic input to the GQA audit program and engage with global quality leadership and stakeholders.
• Define quality strategy and audit plans, applying risk management to cover high-risk activities.
• Ensure vendor work complies with Lilly and external regulatory requirements.
• Stay abreast of regulatory changes and adapt policies accordingly.

Kenntnisse

Quality auditing

Regulatory knowledge

Leadership

Cross-functional collaboration

Ausbildung

Bachelor’s degree in science

Jobbeschreibung

Eli Lilly and Company, headquartered in Indianapolis, seeks a Sr. Director for Global Medical Regulatory Safety to lead the Global Quality Auditing program.

You will drive audits across Clinical Development, Regulatory, Safety/Pharmacovigilance, and Product Quality, partnering with global quality leadership to ensure compliance and strategic quality improvements. You will manage a global staff of auditors, set strategy, and balance resources with audit demands, while engaging with external