Senior Director Global Quality Audit & Regulatory Safety

100 Eli Lilly and Company; 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

Flexible benefits

Life insurance

Time off and leaves

Well-being benefits

Job summary

Lilly, headquartered in Indianapolis, seeks a Sr. Director - GQA Global Medical Regulatory Safety to lead audits across Clinical Development, Regulatory, Safety/Pharmacovigilance and Product Quality.

You will shape the audit program, drive risk-based strategies and align with global quality leadership. Manage a global team of quality auditors, partner with senior leaders to close gaps, and ensure compliance with GMP, GLP and current regulations while supporting Lilly’s corporate goals.

Qualifications

• Education: Bachelor’s Degree or equivalent in a scientific or health-related field.
• Experience: 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.
• Apply risk management principles to make certain the audit plans adequately cover the key risks of Lilly processes, procedures, and facilities, investigational sites, laboratories and contract research organizations, as well as other third-party collaborations.
• Assess whether data reported in support of registration for pharmaceutical products were generated according to applicable international / national regulations and the required corporate policies and procedures.
• Communicate any potential gaps to senior management in a timely manner.
• Based on review of audit findings or trends, highlight key areas for improvement within Clinical Development, Regulatory, Safety/Pharmacovigilance and Product Quality, with appropriate escalation of issues.
• Verify that work performed by vendors complies with Lilly and external regulatory quality requirements.
• Through engagement with pharmaceutical company peers and agency staff, seek to understand the changing regulatory environment, and proactively adapt work and company policies and procedures to align with regulatory expectations.

Skills

Quality auditing

Regulatory affairs

Leadership

GCP/GLP knowledge

Education

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

Advanced degree (Masters, Doctorate)

Job description

Lilly, headquartered in Indianapolis, seeks a Sr. Director - GQA Global Medical Regulatory Safety to lead audits across Clinical Development, Regulatory, Safety/Pharmacovigilance and Product Quality.

You will shape the audit program, drive risk-based strategies and align with global quality leadership. Manage a global team of quality auditors, partner with senior leaders to close gaps, and ensure compliance with GMP, GLP and current regulations while supporting Lilly’s corporate goals.