At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

4. MINIMUM QUALIFICATION REQUIREMENTS

• Bachelor’s or Master’s degree in a health or science-related field at a minimum.
• A minimum of 7 years of direct experience with Clinical Operations, Medical, Safety or Regulatory.
• Experience with quality issue resolution and regulatory inspection.
• Experience working directly with affiliates.
• Demonstrated leadership.
• Demonstrated decision making skills.
• Able to evaluate business needs and develop strategic plans regarding quality improvement.
• Demonstrated ability to operate across boundaries and influence others.
• Strong problem-solving and communication skills (both written and verbal).
• Strong teamwork and interpersonal skills.
• Self-management and motivational ability.
• Customer focused, flexible/adaptable.
• Process improvement oriented.
• Must be able to work autonomously.

PURPOSE

The Associate Director / Director, Global Medicines Quality Organisation (GMQO), leads a team of quality professionals responsible for quality systems, quality oversight and consultation across Medical (Clinical Development and Medical Affairs), Safety and Regulatory activities conducted within assigned functions and/or affiliates in the International Business Unit. This includes the development, execution and oversight of quality systems, management of audit and inspection activities and monitoring of internal metrics and the external environment to maintain compliance to external regulations/internal standards and drive continuous improvement. The role will collaborate with quality, business partners and leadership both locally and across regional/global functions to deliver a robust affiliate quality strategy. The Associate Director / Director will be responsible for a team of GMQO representatives including recruitment, onboarding, coaching and performance management to achieve GMQO objectives and develop talent within the organisation.

PRIMARY RESPONSIBILITIES

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.