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Associate Director

1 month ago

Indianapolis, United States Eli Lilly 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.

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:

  • Ensure appropriate quality systems are in place and the roles and responsibilities of the quality unit are carried for CT drug product manufacturing.
  • Provide direction for day-to-day activities and decisions associated with the manufacturing of CT drug product, escalating when appropriate.
  • Review and approve GMP documentation including complaints, 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, etc.) or auditing.
Additional Skills/Preferences:
  • 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.
  • Previous experience supporting cGMP drug product manufacturing.
  • Proficient with data collection/analysis systems (e.g. SQL, Python, Power Automate, Tableau, PowerBI, etc.).
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 (