Eli Lilly and Company is hiring: PR&D Associate Director CT Packaging and Distri

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.

Compensation: The anticipated wage for this position is $118,500 - $173,800. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The QA Associate Director will provide administrative and technical leadership to a group of individuals that provide Quality oversight for Zone 1 (North and South America) distribution of Clinical Trial (CT) material. This includes oversight and qualification of Third-Party Distribution hubs and depots, daily pick/pack/ship operations, oversight of cold chain logistics projects, and the Temperature Excursion Investigation Centre. This also includes providing Quality oversight for the daily operation of the North American Clinical Trial Distribution facility (K401). The QA Associate Director will also provide administrative and technical leadership to a group of individuals that provide Quality oversight for CT labels and sample management.

Basic Requirements:

• Bachelor’s degree or greater in chemistry, Biology, Pharmacy, Engineering, or other physical science.
• 5+ years of industry-related experience.

Travel Requirement:

• 10 – 15% including international travel.

Skills Required:

• Experience effectively managing a scientific or quality organization.
• Detailed knowledge of regulatory expectations related to Quality.
• Proven track record of driving continuous improvement.
• Excellent collaboration and communication skills.
• Previous experience in commercial, PR&D, or PR&D QA desirable.
• Detailed scientific knowledge and experience in labelling and/or distribution desirable.
• Experience working with Collaboration Partners (CPs) or other external partners desirable.

Key Responsibilities:

• Provide administrative and technical leadership to the QA group supporting Distribution, Licensing, Temperature Excursion, Labelling, and Sample Management.
• Ensure appropriate quality systems are implemented, and the roles and responsibilities of the quality unit are carried out for all CT Distribution activities in Zone 1 and K401.
• Provide Quality oversight and ensure roles and responsibilities of the quality unit are carried out for all Site Temperature Excursion (TEIC).
• Ensure roles and responsibilities of the quality unit are carried out and all applicable licenses are in place to enable K401 operation.
• Support through effective quality oversight of CPs/Service Providers (SPs) that provide services for CT distribution in Zone 1 (e.g., carriers, shipping containers, warehousing, receipt, sampling, destruction, shipping, etc.) and labelling services.
• Approve GMP documents as required by appropriate procedures.
• Escalate quality decisions to the appropriate level for final resolution.
• Ensure appropriate and complete deviation and change controls are completed, impact determined, and corrective measures are identified and implemented effectively.
• Drive transformation and continuous improvements within the quality processes for oversight of areas of responsibilities.
• Ensure quality deliverables within areas of responsibilities are completed effectively and on-time to support the PR&D pipeline.

*This role requires the individual to be onsite three days per week.