Director, Global Quality Assurance & Regulatory Safety

BioSpace; Indianapolis (IN); On-site; USD 164,000 - 240,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Well-being benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Sr. Director for GQA Global Medical Regulatory Safety to lead the audit program across Clinical Development, Regulatory Affairs, Safety/Pharmacovigilance, and Product Quality.

The role involves strategic planning, risk-based audit prioritization, and global team leadership. Responsibilities include defining quality strategy, managing budgets, and ensuring compliance with evolving regulatory expectations, while delivering high-impact

Qualifications

• Bachelor’s Degree or equivalent in a scientific or health-related field.
• Minimum of five (5) years relevant industry experience in quality, clinical development, safety or regulatory affairs.
• Prior line management experience.

Responsibilities

• Lead the definition of the quality strategy and GQA audit plans for the areas of responsibility, applying risk management to cover key risks.
• Manage and provide leadership to a global staff of quality auditors in support of the GQA program.
• Communicate potential gaps to senior management in a timely manner; escalate issues as needed.

Skills

Quality auditing

GxP audits

Regulatory affairs

Leadership

Cross-functional collaboration

Problem solving

Communication

Education

Bachelor’s Degree or equivalent in a scientific or health-related field

Advanced degree (Masters/Doctorate) in a scientific or health-related field

Tools

Quality systems proficiency

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a Sr. Director for GQA Global Medical Regulatory Safety to lead the audit program across Clinical Development, Regulatory Affairs, Safety/Pharmacovigilance, and Product Quality.

The role involves strategic planning, risk-based audit prioritization, and global team leadership. Responsibilities include defining quality strategy, managing budgets, and ensuring compliance with evolving regulatory expectations, while delivering high-impact