Manager, Product Quality

Regulatory Toolkit; Indianapolis (IN); Híbrido; USD 66.000 - 169.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company bonus

Comprehensive benefits package

401(k) matching

Descripción de la vacante

Lilly in Indianapolis seeks a Manager of Product Quality to oversee quality activities across development and commercial-stage products, ensuring compliance and continuous improvement throughout the lifecycle.

You will lead quality investigations, support manufacturing campaigns, review deviations and CAPAs, and collaborate with Regulatory Affairs, Supply Chain, and Manufacturing to support submissions and inspections.

Formación

• BS/MS in Life Sciences.
• 5-10 years pharmaceutical quality experience.
• Knowledge of GMP manufacturing and quality systems.
• Adaptive problem solver with growth mindset and curiosity about AI/digital.

Responsabilidades

• Lead Product Quality for assigned program(s).
• Investigate and finalize reporting for potential product complaints.
• Support Clinical Operations in evaluating product temperature excursions.
• Support manufacturing campaigns and release activities.
• Ensure archival for key manufacturing documentation.
• Review deviations, investigations, CAPAs, and change controls for adequacy.
• Analyze and report on product quality trends.
• Develop risk assessments and mitigation activities with routine monitoring.
• Collaborate with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing for regulatory submissions.
• Support inspections and audits.

Conocimientos

GMP knowledge

Quality systems

Problem solving

Growth mindset

AI exploration

Educación

Life Sciences degree

Descripción del empleo

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.

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as Great Place to Work® in 2026.

Position Overview

Manager of Product Quality will oversee product quality activities across development and commercial-stage products, ensuring quality performance, compliance, and continuous improvement throughout the product lifecycle.

Responsibilities

• Serve as Product Quality Lead for assigned program(s).
• Investigate and finalize reporting activities for potential product complaints
• Support Clinical Operations as required in the evaluation of product temperature excursions
• Support manufacturing campaigns and release activities.
• Ensure archival for expedient retrieval of key manufacturing documentation
• Review deviations, investigations, CAPAs, and change controls for adequacy.
• Analyze and report on product quality trends
• Facilitate the development of risk assessments and mitigation activities and perform routine risk monitoring activities.
• Partner with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to support regulatory submissions.
• Support inspections and audits.

Basic Requirements:

• BS/MS in Life Sciences.
• 5-10 years pharmaceutical quality experience.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Knowledge of GMP manufacturing and quality systems.

Additional Preferences:

• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn’t clear.
• Leverage technical depth and a growth mindset to make impact; imagine what’s possible and pursue it with intention and energy.
• Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital.

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

$66,000 - $169,400

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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