External Manufacturing QA Documentation Lead

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks an EM Quality Assurance QA Representative to oversee documentation management across DPEM, DryEM, and APIEM. The role advances GMP‑regulated practices, data integrity, and training alignment within a global quality framework.

Responsibilities include audit readiness, SOP revisions, and supporting external manufacturing partnerships while promoting continuous improvement and system automation. Shift is days with occasional travel.

Qualifications

• Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• 2+ years of GMP‑regulated pharmaceutical experience with document control, quality systems, or compliance.

Responsibilities

• Serve as the primary point of contact for documentation management across Drug Product External Manufacturing (DPEM), Dry External Manufacturing (DryEM), and APIEM.
• Represent the organization in global QualityDocs forums, leading key initiatives and cross‑functional collaboration.
• Champion continuous improvement and automation within EM documentation practices.
• Provide oversight and maintain document management and data integrity SOPs and guidance documents.

Skills

Attention to detail

Teamwork

Strong communication

Independence

Computer system proficiency

Education

Bachelor's Degree in a science related field

Tools

Trackwise

QDocs

ServiceNow

SuccessFactors

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks an EM Quality Assurance QA Representative to oversee documentation management across DPEM, DryEM, and APIEM. The role advances GMP‑regulated practices, data integrity, and training alignment within a global quality framework.

Responsibilities include audit readiness, SOP revisions, and supporting external manufacturing partnerships while promoting continuous improvement and system automation. Shift is days with occasional travel.