Manager, Product Quality

100 Eli Lilly and Company; États-Unis; À distance; USD 66 000 - 169 000; Plein temps

Résumé du poste

Lilly in the United States is seeking a Manager of Product Quality to oversee quality activities across development and commercial-stage products, ensuring quality performance, compliance, and continuous improvement throughout the product lifecycle.

The role collaborates with Technical Operations, Regulatory Affairs, and Manufacturing teams to support regulatory submissions. Requires a BS/MS in Life Sciences and 5–10 years of pharma quality experience, with US work authorization.

Qualifications

• BS/MS in Life Sciences required.
• 5–10 years pharmaceutical quality experience.
• Authorized to work in the United States on a full-time basis.

Responsabilités

• Serve as Product Quality Lead for assigned program(s).
• Investigate and finalize reporting activities for potential product complaints.
• Support Clinical Operations as required in 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 development of risk assessments and mitigation activities.

Connaissances

US work authorization

GMP knowledge

Quality systems

Pharma quality experience

Formation

BS/MS in Life Sciences

Description du poste

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—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 a 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.

Employee Resource Groups (ERGs)

• 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)
• 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).

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).

• 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
• 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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly