New · posted Oct 24
Eli Lilly · Pharmaceuticals
Associate Director - Quality Control, Gene Therapies
- Lebanon, IN
- On-site
- Full-time
- Director
The role
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.
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.
What you need
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.
What you'll do
- 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.
Pay and benefits
$124,500 – $202,400 a year
Employer providedCompany bonus
401(k)
Pension
Medical, dental, vision and prescription drug benefits
Flexible spending accounts
Vacation and time off benefits
Where you'll work
Lebanon, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Lebanon, INJob intelligence
The context around this role
Live data · October 25, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% below the US median for Quality Control roles at this level.
This roleEmployer provided
Director roles in the US26 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $124,500 | — | $202,400 |
| All US (middle half) | $185,250 | $198,000 | $234,875 |
This role: Eli Lilly's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 25, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 323 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Lilly's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods13
- Collaboration and leadership9
- GMP and compliance6
- Documentation and SOPs1
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Lilly on Regulatory Jobs
- 52
- Open roles
- 52
- Distinct roles
- 10
- Locations
By discipline
- Quality40 77%
- Regulatory11 21%
- Compliance & Safety1 2%
By level
- Director20 38%
- Senior & Principal20 38%
- Associate & Specialist8 15%
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Associate Director - Quality Control, Gene Therapies at Lilly
Open until filled. $125K–$202K a year, employer provided.