Senior QA/API - External Manufacturing & Compliance Lead

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

Benefits offered by this job

401(k) plan

Medical, dental, vision benefits

Pension

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks an API EM Quality Assurance Consultant to oversee quality activities at Contract Manufacturing sites. You will ensure batches meet specifications, comply with cGMPs, and support regulatory commitments.

You will coordinate QA responsibilities for API shipments, participate in inspections, and work with Lilly QA management to drive quality improvements across manufacturing operations. A science degree and GMP experience are required.

Qualifications

• Bachelor's degree in a science-related field required.
• At least 2 years GMP manufacturing experience in API/pharma.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Serve as liaison between Contract Manufacturers (CMs) and Lilly for quality issues.
• Provide quality oversight of CMs and be the initial point of contact for QA matters.
• Escalate quality issues to Lilly QA management and ensure corrective actions.
• Assist in establishing and revising Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and MRDs and review documentation prior to batch release.
• Participate in regulatory inspections and provide on-site support during inspections.
• Review and approve documents including procedures, MBRs, deviations, and change controls.
• Participate in productivity and process improvement initiatives.

Skills

Quality assurance

Regulatory knowledge

Quality systems

Communication

Education

Bachelor's degree in science

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks an API EM Quality Assurance Consultant to oversee quality activities at Contract Manufacturing sites. You will ensure batches meet specifications, comply with cGMPs, and support regulatory commitments.

You will coordinate QA responsibilities for API shipments, participate in inspections, and work with Lilly QA management to drive quality improvements across manufacturing operations. A science degree and GMP experience are required.