Associate Director - Quality Control, Gene Therapies

Regulatory Jobs; Lebanon (IN); On-site; USD 125,000 - 202,000; Full time

Benefits offered by this job

Company bonus

401(k)

Health insurance

Life insurance

Job summary

Lilly is building LP2 in Lebanon, Indiana, to manufacture advanced therapies and gene therapy products. The Site QC Lead will define QC strategy for internal and external labs, oversee start-up operations, and ensure compliant testing and release of materials.

You will collaborate with site leadership and external partners to support timely product delivery. The role demands extensive cGMP experience, robust laboratory leadership, and readiness for ongoing inspections, with a focus on quality

Qualifications

• 8+ years of cGMP commercial manufacturing experience in QC or related disciplines.
• 8+ years of direct laboratory leadership and supervision of QC personnel.
• Experience with regulatory inspection readiness and executing inspections.

Responsibilities

• Set site QC strategy for internal and external laboratory operations including receipt, test, release, and stability samples.
• Size and shape the site’s analytical footprint with leadership alignment for current and future programs.
• Provide laboratory leadership during start-up and ongoing operations; plan workload and ensure compliance.
• Oversee external partner testing to maintain quality standards and oversight.
• Ensure adherence to procedures, methods, and regulatory commitments; lead audit readiness.

Skills

cGMP

QC leadership

Laboratory leadership

Regulatory inspections

Start-up experience

Education

Bachelor's degree in science

Tools

Root Cause Analysis

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities, including Gene Therapy. Located in Lebanon, Indiana, this facility (LP2) will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. 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 design, commission, and start up the facility for both clinical and commercial supply. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

The Site QC Lead sets quality control strategy for LP2’s Advanced Therapies operations, covering both internal laboratory operations and external CDMO/contract laboratory testing for gene therapy and other advanced therapy modalities. This role provides laboratory leadership during facility startup and ongoing operations, ensuring the QC organization is capable of receipt, testing, and release of incoming materials, in-process, release, and stability samples for products manufactured at LP2 or by external partners. The Site QC Lead supports strategic siting, staffing, and equipment decisions that shape the site’s analytical footprint, partnering with site leadership, global laboratory leadership, and external partners to ensure timely, compliant, and inspection-ready testing delivery.

Responsibilities:

• Set site QC strategy for internal and external laboratory operations, ensuring capability to receipt, test, and release incoming materials, in-process, release, and stability samples for products manufactured at LP2 or by external partners.
• Support strategic siting, resourcing, and equipment decisions for the QC organization, partnering with site leadership and global laboratory leadership to size and shape the site’s analytical footprint against current and future program needs.
• Provide laboratory leadership for LP2 QC’s start-up and ongoing operations, managing day-to-day workload planning, compliance, and interaction with GFD and construction teams during facility build-out.
• Oversee laboratory testing performed by external partners for products manufactured by LP2 or third-party manufacturers, ensuring consistent quality standards and effective CDMO/contract laboratory quality oversight.
• Monitor and ensure compliance to procedures, methods, and regulatory commitments, and lead inspection readiness activities and participation in internal audits and external regulatory inspections.
• Develop QC personnel through mentoring, coaching, and career planning, fostering a strong quality culture and effective cross-functional collaboration.

Basic Qualifications:

• Bachelor’s degree in a science field related to chemistry, microbiology, biology, or another science discipline.
• 8+ years of cGMP commercial manufacturing experience in QC or associated disciplines such as Manufacturing, TS/MS, Quality Assurance, or Engineering.
• 8+ years of direct laboratory leadership and supervision of QC laboratory personnel.

Additional Skills/Preferences:

• Knowledge of and/or experience with advanced therapies (e.g., gene therapy, viral vector), including large molecule and/or viral vector testing techniques.
• Previous experience in/ with management of laboratories or start-up of new laboratories.
• Proficient in Root Cause Analysis methodology and other strong problem-solving approaches.
• Proven ability to build strong interpersonal relationships and lead through continuous improvement.
• Prior work with regulatory inspection readiness and inspection execution.
• Deep understanding of compliance requirements and regulatory expectations for GMP laboratory operations.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $124,500 - $202,400.

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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