Global Quality & Regulatory Safety – Senior Director

Lilly

Indianapolis (IN)

On-site

USD 164,000 - 240,000

Full time

9 days ago

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Benefits offered by this job

Company bonus

Comprehensive benefits package

401(k) retirement plan

Job summary

Lilly, headquartered in Indianapolis, IN, seeks a Sr. Director of GQA Global Medical Regulatory Safety to lead a global quality auditing program ensuring GxP compliance across Clinical Development, Safety, Regulatory, and Product Quality.

You will shape the audit strategy, manage a global team, and drive continuous improvement while aligning with evolving regulatory expectations. Located at Lilly Corporate Center, this role requires travel up to 10% and offers a competitive bonus and

Qualifications

Bachelor’s degree or equivalent in a scientific or health-related field.
Minimum of five years in quality, clinical development, safety or regulatory affairs.
Prior line management experience.
Advanced degree (Masters, Doctorate) in a scientific or health-related field.
Experience in multiple facets of drug development and quality assurance/auditing.

Responsibilities

Lead Global Quality Auditing teams auditing Lilly units and affiliates across GCP, GLP, GVP, Regulatory Affairs and Product Quality.
Set quality strategy and audit plans; apply risk management to focus on high-risk activities.
Monitor regulatory expectations and adapt policies accordingly.
Manage global staff, budget, and headcount; participate in strategic planning and decisions.
Provide development plans and mentorship; ensure resources and training.