PRD QA Sr. Director CT DP Manufacturing

1 month ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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.

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 PRD QA Director – DP CT Manufacturing, you will lead the team responsible for the oversight of all drug product (DP) manufactured for use in clinical trials. This manufacturing is executed internally within the B358 CT pilot plant located in Indianapolis at LTCN, the Singapore clinic, and at partner sites across the globe.

As the PRD QA Sr. Director – CT DP Manufacturing, you will lead a team that provides oversight and executes batch release processes for all DP used for clinical trials. This includes oral solid dosage (OSD), parenteral products (inclusive of cell and gene therapies), extemporaneously prepared (EP) products, and devices manufactured by the Clinical Supply Planning and Delivery organization. Manufacturing occurs internally within the B358 clinical trial pilot plant, at intracompany partners (e.g. PR05, IPM, Sesto, etc.), and also externally at collaboration partners (CPs). You will manage the department's workload, conduct performance planning, and coach employees. You will also ensure DP manufacturing is carried out in a compliant manner in accordance with current Quality Standards, Quality Agreements, and current Good Manufacturing Practices (cGMPs).

Responsibilities:

Maintain staffing with the right training, education, and experience to carry out the roles and responsibilities of the Quality Unit.Ensure appropriate decisions are made when issues are escalated (e.g. complaints, deviations, potential retrievals, etc.).Influence cross-functional manufacturing groups to maintain and improve the quality system.Ensure that QA review and/or approval occurs for various cGMP documents including Quality Plans, Quality System documents, deviations, change controls, protocols, batch records, audit related documents, etc.Foster an inclusive environment where continuous improvement and innovative ideas are implemented.Ensure a self-inspection program is in place and participate in internal and external audits.Manage relationships with multiple manufacturing partners across the globe.
Requirements: ​BS, MS or PhD in Pharmacy, Engineering, or Physical SciencesAt least 10 years' experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.)Past leadership experienceDemonstrated problem solving skills and a broad knowledge of DP manufacturing, quality system, and global quality standards.
Additional: An understanding of Regulatory agency requirements such as the FDA, EMEA, ICH, particularly in the area of cGMPs.Demonstrated solid judgment and initiativePrevious experience working effectively with external partnersProficient in data visualization/analysisPrevious experience in devicesPrevious experience in cell and/or gene therapiesOccasional travel (

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