Associate Director QA - PRD API

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 35,000 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 QA Associate Director, CT API Manufacturing, you will lead the team responsible for the oversight of CT active pharmaceutical ingredient (API) manufacturing. This manufacturing is executed internally within the K360 clinical trial pilot plant located in Indianapolis at LTCN and at partner sites across the globe.

Responsibilities:

As the QA Associate Director, you will lead a team that provides oversight and executes batch release processes for all API used for clinical trials. The API includes biologics and chemically synthesized molecules (traditional small molecules, peptides, etc.) manufactured internally in the K360 clinical trial pilot plant, by intracompany partners (e.g. Kinsale, Branchburg, IAPI), and externally by collaboration partners (CPs). You will manage the department's workload, conduct performance planning, and coach employees. You will also ensure API/drug substance 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:

• Ensure appropriate quality systems are in place and the roles and responsibilities of the quality unit are carried out for CT API manufacturing.
• Provide direction for day-to-day activities and decisions associated with the manufacturing of CT API, escalating when appropriate.
• Review and approve GMP documentation including deviations, changes, procedures, and training.
• Ensure a self-inspection program is in place and participate in internal and external audits.
• Influence cross-functional manufacturing groups to maintain and improve the quality system.
• Foster an inclusive environment where continuous improvement and innovative ideas are implemented.
• Manage relationships with multiple manufacturing partners across the globe.

Basic Requirements:

• Bachelor's degree in engineering or science-related field
• At least 5 years' experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.)

Additional Skills/Preferences:

• Previous experience supporting cGMP API/drug substance manufacturing (QA, TSMS, operations, engineering, auditing, etc.)
• Proven ability to lead a team and develop employees
• Proficient in influencing complaint/deviation/change authors via both verbal and written feedback
• Proven ability to envision and oversee implementation of continuous improvements
• Previous QA experience
• Previous audit experience
• Proficient with data collection/analysis systems (e.g. SQL, Python, Power Automate, Tableau, PowerBI, etc.)

Additional Information:

• Position leads a team based in Indianapolis
• Occasional travel (< 10%) will be required for collaboration partner oversight, training, conferences, etc.

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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