Director - Global Analytical Third Party Oversight

at  Lilly

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.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$111,000 - $178,200
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.
Eli Lilly and Company is dedicated to bringing innovation to patients and is growing its manufacturing operations significantly to meet the demand for our medicines. As a result, our Global Quality Analytical & QC Operations (AQCO) team is also growing.
The Director - Global Analytical Third Party Oversight within Global Analytical Quality and QC Operations (AQCO, formerly GQL) involves overseeing the use of external laboratories across Lilly Commercial Manufacturing and Quality. The successful candidate will serve as a key liaison between Lilly and external analytical contract laboratories. Additionally, they will support cross-functional Lilly teams to deliver business results, ensuring effective collaboration and strategic alignment with Lilly’s overarching objectives.

BASIC REQUIREMENTS:

• Bachelor’s degree or equivalent in scientific/engineering discipline is required
• A minimum of 5 years of relevant GMP lab experience

ADDITIONAL SKILLS/PREFERENCES:

• Previous 3rd party analytical oversight experience
• Previous site QC/QA experience
• Ability to effectively manage and prioritize competing priorities
• Strong verbal and written communication skills
• Understanding and experience of LIMS systems
• Relevant cross-functional assignments
• Knowledge of cGMPs and Lab Quality systems
• Ability to function effectively in a team environment.
• Knowledge of drug substance and drug product commercialization process

• Establishing effective relationships with strategic Analytical Contract Laboratories, including participation in Joint Management Teams (JMTs) and/or supporting Executive Steering Committees (ESCs) as needed.
• Establishing and maintaining Global Quality Agreements between Lilly and strategic Analytical Contract Laboratories.
• Establishing and maintaining business outsourcing and insourcing contracts (FTE, FFS, and/or PSS) with Analytical Contract Laboratories.
• Effectively managing and monitoring Lilly commercial projects and activities involving Analytical Contract Laboratories.
• Interacting with AQCO Analytical Stewards, supporting method transfer, validation and other projects conducted externally.
• Enhancing internal collaboration with PR&D, procurement, DPEM and APIEM on the oversight of Analytical Contract Laboratory relationships.
• Sharing information with Global Quality to facilitate Inspection Readiness Assessments of Analytical Contract Laboratories.
• Supporting Lilly’s technical leadership and project management to drive business results and improvements with Analytical Contract Laboratories.