Sr. Director- GQA Global Medical Regulatory Safety

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Sr. Director- GQA Global Medical Regulatory Safety

This role leads the Global Quality Auditing (GQA) teams responsible for executing audits of operating units in Clinical Development (GCP), ATPLV: ADME (Absorption, Distribution, Metabolism, and Excretion), Toxicology, PK/PD (Pharmacokinetics/Pharmacodynamics), LEM (Laboratory for Experimental Medicine), Veterinary Resources (GLP), Global Patient Safety/Pharmacovigilance (GVP), Regulatory Affairs and Product Quality, including conducting GxP audits of operations in Lilly's affiliates. These audits serve to ensure that research conducted and sponsored by the Company, as well as product and disease state information shared with customers are in accordance with Company policies, practices and procedures and in compliance with current regulations and guidelines.

The broad scope of auditing managed by the Sr. Director requires that the Sr. Director provides strategic input to the overall GQA audit program and interacts effectively with global quality leadership and business unit stakeholders. The Sr. Director is responsible for staying abreast of the changing environment, both internal business priorities and external regulatory expectations, to identify and focus continuous improvement efforts.

• Understand the strategic and operating needs of the primary business areas to ensure that resources and quality improvements are focused on high‑risk business activities. 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.

• Manage and provide leadership to a global staff of quality auditors in support of the implementation of the GQA audit program, objectives, and business operations.

• Participate in component‑wide QA strategic planning meetings. Define strategy and action plans to continue to strengthen our GQA organization supporting Lilly’s corporate goals and objectives.

• Understand and extensively network with the LRL functional business area…