Site Quality Leader - Foundry at Eli Lilly and Company

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

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.                     

Main Purpose and Objectives of Position:   

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 Sr. Director – Site Quality Leader for the Lilly Medicines Foundry, you will establish and lead the team responsible for the quality oversight of drug substance (DS) manufacturing and supporting systems for use in clinical trials.  This manufacturing is executed at the state-of-the-art Foundry Site located in Lebanon Indiana. Your leadership will directly impact the successful delivery of our pipeline, ensuring that every product meets current quality standards and regulations.

Scope: 

BR&D API, SMDD API, Hybrid API (Oligonucleotides, conjugates, etc.), Facilities, Utilities, and Maintenance & Engineering (FUME), Computer Systems Quality (CSQ), and GMP testing.

Key Responsibilities: 

As Sr. Director – Site Quality Leader for Foundry, you will lead a team that provides partnership across all processes connected to the Foundry.  This includes the oversight and execution of batch release processes of chemically synthesized molecules (traditional small molecules, peptides etc.), biologics, and novel hybrid technologies (oligonucleotides, conjugates, etc.) technology transferred to the Foundry by the Synthetic Molecule Design and Delivery (SMDD) and Biosynthetic Research and Development (BR&D) organizations respectively. You will also supervise the QA personnel responsible for facilities, utilities, maintenance, engineering (FUME), gmp testing and computer systems quality (CSQ).  You will manage the department’s workload, conduct performance planning, and coach employees.  You will also ensure API/ DS manufacturing is carried out in a compliant manner in accordance with current Quality Standards, Quality Agreements, and current Good Manufacturing Practices (cGMPs).  You are also a core member of the Foundry Site Lead Team. 

Additional specific responsibilities include: 

• Maintain staffing with the right training, education, and experience to carry out the roles and responsibilities of the Quality Unit. 

• Ensure appropriate decisions are made when issues are escalated (e.g. complaints, deviations, potential retrievals, etc.). 

• Foster an inclusive environment where continuous improvement and innovative ideas are implemented. 

• Influence cross-functional manufacturing groups to maintain and improve the quality system. 

• Ensure that QA review and/or approval occurs for various cGMP documents including Quality Plans, Quality System documents, deviations, change controls, protocols, batch records, audit related documents, etc. 

• Ensure a self-inspection program is in place and participate in internal and external audits. 

Basic Requirements:

• BS, MS or PhD in Pharmacy, Engineering, or Physical Sciences

• At least 8 years’ experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.) 

• Past leadership experience

Additional Preferences:             

• Demonstrated problem solving skills and a broad knowledge of API/DS manufacturing, quality system, and global quality standards. 

• An understanding of Regulatory agency requirements such as the FDA, EMEA, ICH, particularly in cGMPs 

• Demonstrated solid judgment and initiative 

• Proficient in data visualization/analysis 

• Preferable, prior experience in other partnered functions (Ops, TSMS, Engineering, etc.)

• Preferable, experience with digital systems and compliant deployment in development environments (EBR, MES, ELN, etc.)

Additional Information:

• Occasional travel (<10%) will be required for, training, conferences, etc. 

• This position will be based in Indianapolis until the site for the Foundry in Lebanon, IN is able to be occupied.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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