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.
Organization Overview:
Product Research and Development (PRD) quality assurance (QA) supports the delivery of the Lilly pipeline by providing oversight of the manufacturing, packaging, and distribution of the medicines needed for clinical trials (CT). As the Associate Director-QA, CT Drug Product Manufacturing, you will lead the team responsible for the oversight of CT drug product manufacturing. This manufacturing is executed at partner sites across the globe, both internally and externally.
Responsibilities:
As the Quality Assurance Associate Director, CT Drug Product Manufacturing, your team will execute batch release processes and provide oversight of product manufactured internally by intracompany partners and externally by collaboration partners (CPs). You will manage the department’s workload, conduct performance planning, and coach employees. You will also ensure drug product manufacturing is carried out in a compliant manner in accordance with current Quality Standards, Quality Agreements, and current Good Manufacturing Practices (cGMPs). Additional specific responsibilities include:
Basic Requirements:
Bachelor’s degree in engineering or science-related field.At least 5 years’ experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, etc.) or auditing.
Additional Skills/Preferences:
Additional Information:
Position leads a team based in Indianapolis, Indiana.This is a flexible/hybrid role with an expectation to be on site at least 3 days a week.Occasional travel (