Senior QA Lead for API Manufacturing & Compliance

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

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Paid time off

Job summary

Eli Lilly and Company in Indianapolis invites a QA-focused professional to join our API/Pharma Quality Assurance team. You will serve as a liaison between CMs and Lilly, oversee quality for shipments, and escalate issues to Lilly QA management for timely resolution.

Responsibilities include ensuring compliance with quality agreements, reviewing master records and validation documents, and supporting regulatory inspections. Requires GMP experience and US work authorization.

Qualifications

• Bachelor's degree in a science-related field (Pharmacy/ Chemistry/ Biological Sciences or related Life Sciences).
• At least 2 years GMP manufacturing experience in API or Pharmaceutical finished product, QC, QA or Engineering.
• Authorized to work in the United States full-time; Lilly does not sponsor work authorization or visas.
• Experience in quality support for QC activities
• Thorough understanding of quality systems and regulatory requirements
• Knowledge of pharmaceutical manufacturing operations
• Demonstrated coaching and mentoring skills
• Experience in root cause analysis
• Demonstrated application of statistical skills

Responsibilities

• Serve as liaison between CMs and Lilly and provide quality oversight.
• Escalate quality issues at CMs to Lilly QA management and assist in Quality Agreements.
• Ensure compliance to Quality Agreements and MRDs and review documents for batch release.
• Coordinate QA responsibilities of API shipments from suppliers and CMs; participate in inspections.
• Review documents including procedures, master production records, deviations, changes and validations.
• Participate in APR, productivity projects, JPT and PLOT teams.

Skills

GMP manufacturing experience

Quality systems knowledge

Regulatory compliance understanding

Coaching and mentoring skills

Root cause analysis

Statistical skills

Education

Bachelor's degree in science-related field

Job description

Eli Lilly and Company in Indianapolis invites a QA-focused professional to join our API/Pharma Quality Assurance team. You will serve as a liaison between CMs and Lilly, oversee quality for shipments, and escalate issues to Lilly QA management for timely resolution.

Responsibilities include ensuring compliance with quality agreements, reviewing master records and validation documents, and supporting regulatory inspections. Requires GMP experience and US work authorization.