Global Quality Audit Director, Medical Regulatory Safety

Regulatory Jobs; Indianapolis (IN); Sur place; USD 164 000 - 240 000; Plein temps

Résumé du poste

Lilly in Indianapolis seeks a Sr. Director for GQA Global Medical Regulatory Safety to lead audit programs across multiple functions, ensuring compliance with GxP and regulatory standards.

The role requires strategic vision, global leadership of a quality auditing workforce, and collaboration with internal and external partners to drive continuous improvement and risk-based decision making.

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.

Responsabilités

• Lead Global Quality Auditing (GQA) teams to audit Clinical Development, Regulatory, Safety/Pharmacovigilance 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 using risk management principles.
• Ensure vendor work complies with Lilly and external regulatory requirements.
• Stay current with regulatory changes and adapt policies to align with expectations.

Connaissances

Quality auditing

Regulatory affairs

GxP audits

Leadership

Cross-functional collaboration

Formation

Bachelor's degree in science

Description du poste

Lilly in Indianapolis seeks a Sr. Director for GQA Global Medical Regulatory Safety to lead audit programs across multiple functions, ensuring compliance with GxP and regulatory standards.

The role requires strategic vision, global leadership of a quality auditing workforce, and collaboration with internal and external partners to drive continuous improvement and risk-based decision making.