Senior Product Quality Lead – GMP & Compliance

Eli Lilly and Company; Indianapolis (IN); On-site; USD 66,000 - 169,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leave benefits

Well-being benefits

Job summary

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

You will lead quality investigations, support operations and regulatory submissions, review deviations and CAPAs, and collaborate with Manufacturing, Regulatory Affairs, and Supply Chain to protect product quality.

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 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.

Skills

Pharmaceutical quality experience

Education

BS/MS in Life Sciences

Job description

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

You will lead quality investigations, support operations and regulatory submissions, review deviations and CAPAs, and collaborate with Manufacturing, Regulatory Affairs, and Supply Chain to protect product quality.