Pharma Product Quality Lead — Impactful, Compliance‑Driven

Eli Lilly and Company; Indiana; On-site; USD 66,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leave

Well-being benefits

Job summary

Eli Lilly and Company is seeking a Manager of Product Quality to oversee quality activities across development and commercial-stage products. You will ensure compliance, drive continuous improvement, and lead risk assessments across the product lifecycle.

This role requires a Life Sciences degree and 5-10 years of pharmaceutical quality experience, along with U.S. work authorization. The position is based in Indianapolis, Indiana, with a focus on quality systems and regulatory submissions.

Qualifications

• BS/MS in Life Sciences.
• 5-10 years pharmaceutical quality experience.
• Authorized to work in the United States on a full-time basis.
• 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 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 risk assessments and mitigation activities; perform routine risk monitoring.

Skills

Adaptive problem solver

Growth mindset

Education

BS/MS in Life Sciences

Job description

Eli Lilly and Company is seeking a Manager of Product Quality to oversee quality activities across development and commercial-stage products. You will ensure compliance, drive continuous improvement, and lead risk assessments across the product lifecycle.

This role requires a Life Sciences degree and 5-10 years of pharmaceutical quality experience, along with U.S. work authorization. The position is based in Indianapolis, Indiana, with a focus on quality systems and regulatory submissions.