Product Quality Lead – Pharma

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 66,000 - 169,000; Full time

Benefits offered by this job

401(k) matching

Pension plan

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being benefits

Job summary

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

Responsibilities include leading product quality efforts, handling investigations, supporting operations, and ensuring proper documentation and audits. A BS/MS in Life Sciences with 5–10 years of quality experience in pharma is required.

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

Adaptive problem solver

Growth mindset

Innovation and AI interest

Education

BS/MS in Life Sciences

Job description

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

Responsibilities include leading product quality efforts, handling investigations, supporting operations, and ensuring proper documentation and audits. A BS/MS in Life Sciences with 5–10 years of quality experience in pharma is required.