Senior Product Quality Lead - Pharmaceuticals

Regulatory Jobs; Indianapolis (IN); Hybrid; USD 66,000 - 169,000; Full time

Benefits offered by this job

Company bonus

Comprehensive benefits package

401(k) matching

Job summary

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

You will lead quality investigations, support manufacturing campaigns, review deviations and CAPAs, and collaborate with Regulatory Affairs, Supply Chain, and Manufacturing to support submissions and inspections.

Qualifications

• BS/MS in Life Sciences.
• 5-10 years pharmaceutical quality experience.
• Knowledge of GMP manufacturing and quality systems.
• Adaptive problem solver with growth mindset and curiosity about AI/digital.

Responsibilities

• Lead Product Quality for assigned program(s).
• Investigate and finalize reporting for potential product complaints.
• Support Clinical Operations in evaluating product temperature excursions.
• Support manufacturing campaigns and release activities.
• Ensure archival for key manufacturing documentation.
• Review deviations, investigations, CAPAs, and change controls for adequacy.
• Analyze and report on product quality trends.
• Develop risk assessments and mitigation activities with routine monitoring.
• Collaborate with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing for regulatory submissions.
• Support inspections and audits.

Skills

GMP knowledge

Quality systems

Problem solving

Growth mindset

AI exploration

Education

Life Sciences degree

Job description

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

You will lead quality investigations, support manufacturing campaigns, review deviations and CAPAs, and collaborate with Regulatory Affairs, Supply Chain, and Manufacturing to support submissions and inspections.