Senior Principal Associate, Quality Systems, Foundry

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.

Overview:

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 are looking for people who are determined to make life better for people around the world.

Lilly is currently constructing an advanced research facility, The Lilly Medicine Foundry, for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly’s largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Note: Final location for this role is Lebanon, IN but flexibility to work from Indianapolis will be required throughout 2025 and 2026.

Position Summary:

The Quality Systems Sr. Principal Associate is responsible for partnering with the Compliance Leader to create, maintain, and improve the Quality Management processes for the Foundry. The Foundry is intended to be highly digital, and this position will have responsibility for providing support and guidance to all functions (e.g. Quality, Manufacturing, Facilities, Development) regarding performance and maintenance of Quality processes at the Foundry. The Quality Systems Sr. Principal Associate will partner with other internal Lilly Quality functions and/or sites to ensure the Foundry Quality Management processes align with and satisfy current and future Lilly Quality standards and industry regulations.

Responsibilities & Scope:

· Support cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness.

· Act as a primary subject matter expert for Quality Management processes, potentially inclusive of:

o Document Control

o Change Management

o Audits | Inspections

o Quality Management review

· Establish the document control and document management function and processes for the Foundry.

· Effectively communicating with and managing internal and external stakeholders.

· Proactively managing issues, proposing, and implementing plans to resolve as needed.

· Promote a positive quality culture and oversee quality presence in the respective business areas (e.g. manufacturing, laboratories).

· Participate in Quality Systems related global communities of practice and committees as appropriate to establish and maintain a network for benchmarking and shared learning.

· Evaluate and approve change controls, risk assessments, deviation investigations, and CAPAs. Recommend CAPAs and ensure CAPAs implemented are effective. Ensure that quality system related changes/deviations are evaluated consistently.

· Identify and lead process improvement projects impacting multiple business areas.

Basic Qualifications:

· BA/BS degree in Science, Engineering, or related field with a minimum of 5 years technical and/or quality experience in the Biopharmaceutical industry, preferably in a GMP manufacturing facility.

· Relevant industry experience in highly paced working environments. Relevant experience with building quality management processes. Experience with Veeva QualityDocs and/or Veeva QMS is highly desirable.

· Strong knowledge of current GMP expectations and application of quality management systems in execution.

Key Attributes for the Role

Demonstration of the following:

· Understanding of Quality Management processes, document control, and data integrity.

· Experience providing Quality Management process support for GMP manufacturing facilities.

· Flexibility to adjust quickly and effectively to frequent change and altered priorities.

· Ability to input and influence decision making for complex technical issues.

· Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.

· Ability to establish key relationships and influence peers and business partners.

· Strong communication skills.

· Ability to identify and prioritize issues, develop, and implement solutions.

· High learning agility and ability to deal with ambiguity, uncertainty.

· Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis.

· Ability to identify through internal and external benchmarking opportunities to continuously improve and innovate quality

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

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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