Site Quality Leader - Foundry

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: January 24, 2025

Job Description:

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 $151,500 - $222,200. Actual compensation will depend on a candidate's education, experience, skills, and geographic location.Main Purpose and Objectives of Position: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 Sr. Director - Site Quality Leader for the Lilly Medicines Foundry, you will establish and lead the team responsible for the quality oversight of drug substance (DS) manufacturing and supporting systems for use in clinical trials. This manufacturing is executed at the state-of-the-art Foundry Site located in Lebanon Indiana. Your leadership will directly impact the successful delivery of our pipeline, ensuring that every product meets current quality standards and regulations.Scope:BR&D API, SMDD API, Hybrid API (Oligonucleotides, conjugates, etc.), Facilities, Utilities, and Maintenance & Engineering (FUME), Computer Systems Quality (CSQ), and GMP testing.Key Responsibilities:As Sr. Director - Site Quality Leader for Foundry, you will lead a team that provides partnership across all processes connected to the Foundry. This includes the oversight and execution of batch release processes of chemically synthesized molecules (traditional small molecules, peptides etc.), biologics, and novel hybrid technologies (oligonucleotides, conjugates, etc.) technology transferred to the Foundry by the Synthetic Molecule Design and Delivery (SMDD) and Biosynthetic Research and Development (BR&D) organizations respectively. You will also supervise the QA personnel responsible for facilities, utilities, maintenance, engineering (FUME), GMP testing, and computer systems quality (CSQ). You will manage the department's workload, conduct performance planning, and coach employees. You will also ensure API/DS manufacturing is carried out in a compliant manner in accordance with current Quality Standards, Quality Agreements, and current Good Manufacturing Practices (cGMPs). You are also a core member of the Foundry Site Lead Team.Additional specific responsibilities include:

• 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.).
• Foster an inclusive environment where continuous improvement and innovative ideas are implemented.
• 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.
• Ensure a self-inspection program is in place and participate in internal and external audits.Basic Requirements:
  • BS, MS or PhD in Pharmacy, Engineering, or Physical Sciences.
  • At least 8 years' experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).
  • Past leadership experience.Additional Preferences:
    • Demonstrated problem-solving skills and a broad knowledge of API/DS manufacturing, quality system, and global quality standards.
    • An understanding of Regulatory agency requirements such as the FDA, EMEA, ICH, particularly in cGMPs.
    • Demonstrated solid judgment and initiative.
    • Proficient in data visualization/analysis.
    • Preferable, prior experience in other partnered functions (Ops, TSMS, Engineering, etc.).
    • Preferable, experience with digital systems and compliant deployment in development environments (EBR, MES, ELN, etc.).Additional Information:
      • Occasional travel (
      • This position will be based in Indianapolis until the site for the Foundry in Lebanon, IN is able to be occupied.
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Keywords: Eli Lilly and Company, Kokomo , Site Quality Leader - Foundry, Other , Indianapolis, Indiana