Manager, Product Quality

Lilly • Indianapolis, IN

2d • $66,000 - $169,400

About The Position

The 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. The role serves as Product Quality Lead for assigned programs and works with internal teams to support manufacturing, product release, regulatory submissions, inspections, and audits.

Requirements

• BS/MS in Life Sciences.
• 5–10 years of pharmaceutical quality experience.
• Knowledge of GMP manufacturing and quality systems.
• Must be authorized to work in the United States on a full-time basis; the company will not sponsor work authorization or visas for this role.

Nice To Haves

• Adaptive problem solver who turns issues into opportunities and translates ideas into solutions, even when the path is unclear.
• Leverages technical depth and a growth mindset to make an impact, imagine what is possible, and pursue it with intention and energy.
• Demonstrates curiosity and drives self-identified innovation, especially in exploring artificial intelligence and digital.

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.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, including 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager