Hybrid Sr. Director - QA Compliance – Lilly Medicine Foundry presso 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.

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 Active Pharmaceutical Ingredient (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 QA Compliance Leader is responsible for leading innovative quality programs and ensuring compliance with GMP standards for manufacturing clinical trial drug substances. This includes monitoring the effectiveness of the quality management system. This role is pivotal in mentoring the team, establishing external networks for quality benchmarking, and advancing the quality culture of the site.

An immediate objective of this position includes designing and implementing the Foundry quality management system, which spans procedures, training, technology tools, and IT systems to ensure consistent execution and compliance. The Compliance Lead will navigate the complex linkages of the project, delivering an efficient quality system that integrates innovation. The Compliance Lead will be responsible for the delivery of governing procedures, training, and needs driven by governing procedures (e.g., IT system set-up, strategy documents, form creation).

Responsibilities & Scope:

• Project management of workstreams for each of the quality systems supporting Foundry. The following are examples of workstreams requiring start-up project management: Batch Release, FUME, Materials Management, Production Support Processes, Sample Management, Stability.
• Support the cross-functional teams, facilitate decision making, drive progress, and provide relevant metrics to governance forums.

• Partnering with relevant stakeholders to ensure clear scope alignment and resulting goals and timelines for the project are met.
• Forecasting resource needs across the integrated plan and anticipating and resolving any projected resource issues before they impact project delivery.
• Establishing key performance indicators and monitoring the effectiveness of the quality management system.
• Engage with industry groups and regulatory bodies, as applicable, for benchmarking and influence of the external environment. 
• Facilitating quality lead teams and reporting on quality metrics and performance to internal and global teams.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicating and managing internal and external stakeholders.
• Proactively managing issues, proposing, and implementing plans to resolve as needed.

Basic Qualifications:

• >8 years relevant industry experience in high paced working environments. Relevant experience of working on large scale capital project deliveries is highly desirable.
• Strong knowledge of the current GMP expectations and application of quality management systems in execution.
• Experience in Active Pharmaceutical Ingredient/Drug Substance manufacturing.

Key Attributes for the Role

• Demonstrated project management and delivery of medium to large cross-functional initiatives.
• Demonstrated ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Demonstrated ability to input and influence decision making for complex technical issues.
• Demonstrated success in coaching, developing personnel, and mentorship.
• Ability to interact with multiple functions and combine work streams into an integrated schedule.
• Demonstrated ability to establish key relationships and influence peers and business partners.
• Demonstrated strong communication skills.
• Demonstrated ability to identify and prioritize issues, develop, and implement solutions.
• High learning agility and flexibility & ability to deal with ambiguity, uncertainty.
• Demonstrated ability to understand/influence integration points with business areas/functions.
• Experience in the drug development process and the development synthetic, biologic, or hybrid technologies.
• Demonstrated learning agility across drug development subject matter with a focus on delivering solutions to complex business challenges.
• Capable to drive and design Key Performance Indicators (KPIs), metrics, and data analysis

Education Requirements:

• Bachelor of Science in scientific or technical degree: chemistry, biology, microbiology, engineering or equivalent scientific / technical degree

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

$151,500 - $244,200

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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