Senior Product Quality Lead – Pharma Innovation

100 Eli Lilly and Company; United States; Remote; USD 66,000 - 169,000; Full time

Job summary

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.

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 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.

Skills

US work authorization

GMP knowledge

Quality systems

Pharma quality experience

Education

BS/MS in Life Sciences

Job description

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.