Senior QA Lead, API Manufacturing & Compliance

Regulatory Jobs; Indianapolis (IN); Sur place; USD 66 000 - 172 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Comprehensive benefits

Pension plan

Résumé du poste

Lilly, headquartered in Indianapolis, Indiana, seeks an API EM Quality Assurance Consultant to support quality activities at Contract Manufacturing organizations. The role ensures batches meet specifications, processes are validated, and regulatory commitments are met.

Key duties include liaison with CMs, QA oversight, updating Quality Agreements, coordinating API shipments, and participating in inspections and JPT/PLOT teams. Travel ~20% is expected; requires a B.S.

Qualifications

• Bachelor-level scientist with GMP/QA experience.
• Knowledge of cGMPs and regulatory commitments.
• Experience with API/Pharma quality oversight and audits.

Responsabilités

• Serve as liaison between CMs and Lilly quality teams.
• Provide QA oversight of CMs and issue escalation.
• Assist in Quality Agreements and MRDs.
• Coordinate QA of API shipments and regulatory prep for inspections.
• Review documents and change controls related to manufacturing.

Connaissances

Quality Assurance

GMP compliance

Regulatory knowledge

Root cause analysis

Statistical skills

Communication

Interpersonal skills

Project coordination

Formation

Bachelors in Science (Pharmacy, Chemistry or Life Sciences)

Description du poste

Lilly, headquartered in Indianapolis, Indiana, seeks an API EM Quality Assurance Consultant to support quality activities at Contract Manufacturing organizations. The role ensures batches meet specifications, processes are validated, and regulatory commitments are met.

Key duties include liaison with CMs, QA oversight, updating Quality Agreements, coordinating API shipments, and participating in inspections and JPT/PLOT teams. Travel ~20% is expected; requires a B.S.