QA Document Control Lead - External Manufacturing (GMP)

Biopharma Careers; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k)

Pension

Medical benefits

Dental benefits

Vision benefits

Job summary

Lilly in Indianapolis, Indiana, is seeking a QA Representative to provide oversight of electronic document management systems (EDMS), documentation control, and data integrity for External Manufacturing Quality Assurance.

The role requires ensuring compliance with GMP standards, supporting audits, SOPs, and training while coordinating with global teams and internal stakeholders. Some travel and day shifts may be required.

Qualifications

• Bachelor's degree in a science-related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• 2+ years of hands-on GMP-regulated pharmaceutical experience with document control or quality systems.
• Authorized to work in the United States on a full-time basis; no visa sponsorship.

Responsibilities

• Oversee documentation management across DPEM, DryEM and APIEM to ensure compliance.
• Liaise between L&D central team and EM for documentation and training initiatives.
• Lead initiatives in global QualityDocs forums and drive cross-functional collaboration.
• Champion continuous improvement and automation within EM documentation practices.
• Act as SME for EM’s Veeva Quality Documents control groups.
• Prepare and deliver training on document management systems.

Skills

Computer systems proficiency

Written and verbal communication

Independence

Teamwork

Education

Bachelor's degree in science-related field

Tools

Trackwise

QDocs

ServiceNow

SuccessFactors

Job description

Lilly in Indianapolis, Indiana, is seeking a QA Representative to provide oversight of electronic document management systems (EDMS), documentation control, and data integrity for External Manufacturing Quality Assurance.

The role requires ensuring compliance with GMP standards, supporting audits, SOPs, and training while coordinating with global teams and internal stakeholders. Some travel and day shifts may be required.