Manager, Product Quality

BioSpace; Indianapolis (IN); On-site; USD 66,000 - 169,000; Full time

Benefits offered by this job

401(k) eligibility

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Prescription drug benefits

Flexible benefits

Life insurance

Death benefits

Time off and leave

Well-being benefits

Job summary

Lilly is seeking a Product Quality Lead to oversee quality activities for assigned programs in the U.S. You will investigate product complaints, support temperature excursion evaluations, and coordinate with Manufacturing, Regulatory, and Supply Chain teams to ensure compliant releases.

Qualifications include a BS/MS in Life Sciences and 5–10 years of pharma quality experience, with knowledge of GMP systems. Compensation ranges from $66,000 to $169,400 annually, with a company bonus opportunity.

Qualifications

• BS/MS in Life Sciences.
• 5–10 years pharmaceutical quality experience.
• Knowledge of GMP manufacturing and quality systems.

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 risk assessments and mitigation activities and perform routine risk monitoring.
• Partner with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to support regulatory submissions.
• Support inspections and audits.

Skills

Quality systems

GMP knowledge

Pharmaceutical quality experience

Education

BS/MS in Life Sciences

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. 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.

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

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.

Equal Opportunity / Diversity Statement

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

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).

Compensation and Benefits

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).

• company-sponsored 401(k) eligibility
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• 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