Senior QA Leader — Global API Manufacturing (GMP)

Lilly; Indianapolis (IN); On-site; USD 100,000 - 170,000; Full time

Job summary

Lilly seeks a Senior/Principal Associate QA for API External Manufacturing to provide quality oversight for contract manufacturing organizations in a GMP environment. You will review and approve batch records, deviations, CAPAs, and change controls; support regulatory inspections; and ensure compliance with global quality and regulatory standards.

You will partner closely with external suppliers and internal technical teams to manage risks, drive continuous improvement, and ensure reliable

Qualifications

• Review and approve batch records, deviations, CAPAs, and change controls.
• Support regulatory inspections and ensure compliance with global quality and regulatory standards.
• Partner with external suppliers and internal teams to manage risk and drive continuous improvement.

Responsibilities

• Provide quality oversight for contract manufacturing organizations within a GMP environment.
• Review quality system records and close out quality events.
• Collaborate with Lilly and external partners to ensure reliable API supply and compliant manufacturing.

Skills

QA Oversight

GMP Compliance

CAPA Management

Batch Records Review

Job description

Lilly seeks a Senior/Principal Associate QA for API External Manufacturing to provide quality oversight for contract manufacturing organizations in a GMP environment. You will review and approve batch records, deviations, CAPAs, and change controls; support regulatory inspections; and ensure compliance with global quality and regulatory standards.

You will partner closely with external suppliers and internal technical teams to manage risks, drive continuous improvement, and ensure reliable