QA Lead - GMP Compliance & Startup

BioSpace; Lebanon (IN); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

Company Bonus

401(k) Plan

Medical Benefits

Job summary

Lilly in Indianapolis, IN is seeking an Associate Director – QA to lead QA workforce, uphold product quality, and ensure regulatory compliance across API manufacturing, laboratories, and warehouses.

You will coach QA teams, oversee deviations, change controls, inspections, and maintain cGMP documentation, while partnering with Sr. Director – QA to drive operations and customer service. This role requires flexibility to support 24/7 operations and occasional travel.

Qualifications

• BS or equivalent in a scientific field or engineering.
• 5+ years in CGMP Manufacturing.

Responsibilities

• Coach and develop QA employees.
• Oversee quality systems and deviations.
• Ensure regulatory compliance and inspections.
• Interact with auditors and inspectors.
• Manage the creation, revision, and maintenance of cGMP documents.

Skills

CGMP Manufacturing

Quality Assurance

Regulatory Leadership

Statistical Tools

People Leadership

Communication Skills

Computer Applications

Education

Bachelor's degree

Job description

Lilly in Indianapolis, IN is seeking an Associate Director – QA to lead QA workforce, uphold product quality, and ensure regulatory compliance across API manufacturing, laboratories, and warehouses.

You will coach QA teams, oversee deviations, change controls, inspections, and maintain cGMP documentation, while partnering with Sr. Director – QA to drive operations and customer service. This role requires flexibility to support 24/7 operations and occasional travel.