Associate Director - QA - Lebanon API

Eli Lilly and Company; Lebanon (KY); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

Company bonus

Job summary

Lilly is seeking a Quality Assurance Associate Director to provide quality oversight of LP1 API manufacturing and to lead QA teams in ensuring regulatory compliance and continuous improvement. The role focuses on commissioning readiness, issue resolution, and cross-functional collaboration.

The candidate will guide QA staff, mentor manufacturing representatives, and ensure adherence to cGMP and global quality standards across the site in Lebanon, Indiana.

Qualifications

• BS in Engineering or science related field (required).
• 5+ years in CGMP manufacturing.
• Experience leading QA teams and coordinating with cross functional groups.

Responsibilities

• Provide direct quality oversight to LP1 manufacturing and guide QA staff.
• Lead resolution of quality issues and support inspection readiness.
• Coordinate with cross functional teams to achieve QA objectives.
• Prepare for internal and external regulatory inspections and ensure site QA systems align with standards.
• Coach and mentor QA manufacturing representatives in QA support and investigations.

Skills

Leadership

QA oversight

Problem solving

Communication

Technical aptitude

Regulatory knowledge

Root cause investigations

Training/mentoring

Education

BS in Engineering or science related field

Tools

CGMP

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.

Lilly is currently constructing an advanced manufacturing facility for production of Active Pharmaceutical Ingredient (API) molecules located in Lebanon, Indiana, USA. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility, and the culture to enable a successful startup into GMP manufacturing operations

Job Position Overview:

The Quality Assurance Associate Director provides quality oversight to the API manufacturing processes. The Associate Director is responsible for managing the development of direct reports and prioritizing work appropriately to implement LP1 and QA objectives. This position will have a primary focus on the oversight of operational readiness and initiation of production within the synthetic peptide facilities. The role has responsiblity to oversee the team’s performance, resolution of quality issues and compliance.

Responsibilities:

• Provide direct quality oversight to LP1 manufacturing and assist others in interpretation of regulatory and corporate requirements

• Provide quality guidance, technical support and recommendations to equipment and process issues and continuous improvement initiatives. Lead resolution of quality issues.

• Work with cross functional teams to implement QA objectives

• Prepare for and participate in internal and external regulatory inspections. Lead the broader QA team in maintaining and improving site quality sysetms, ensuring alignment with global quality standards and external regulations.

• Guide and coach QA manufacturing staff, including performance management and career development.

• Coach and mentor QA manufacturing representatives in aspects of QA support including process understanding, problem solving, project management and deviation investigation/resolution.

Basic Requirements:

• BS in Engineering or science related field

• 5+ years in CGMP manufacturing

Additional Skills/Preferences:

• Previous leadership experience in pharmaceutical industry

• Prior experience with synthetic peptide manufacturing, in QA, TS/MS, QC or Engineering

• Demonstrated problem solving and decision making skills

• Demonstrated strong written and verbal communication skills, with a strong attention to detail

• Strong technical aptitude, analytical thinking skills and ability to train and mentor others

• Prior work with cGMPs or external regulations

• Previous experience with root cause investigations

• Strong knowledge of Quality Management Systems and applicable regulatory requirements

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$123,000 - $180,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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