Senior / Principal QA: API External Manufacturing Champion

Regulatory Jobs; Indianapolis (IN); Vor Ort; USD 65.000 - 169.000; Vollzeit

Zusammenfassung

Eli Lilly and Company is seeking a Senior/Principal Associate QA API External Manufacturing to ensure quality and compliance of externally manufactured APIs in line with cGMP regulations. The role involves significant oversight and collaboration with external manufacturing partners.

Responsibilities include reviewing documentation, leading audits, managing deviations and CAPAs, and supporting tech transfers and regulatory interactions. Travel up to 25% may be required.

Qualifikationen

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
• Minimum 5 years (Senior) or 8 years (Principal) QA experience in pharmaceutical/biopharmaceutical industry with focus on API manufacturing or external supply chain quality.
• In-depth knowledge of cGMP regulations and international quality standards applicable to API manufacturing.
• Experience auditing external manufacturing sites and managing quality events (deviations, investigations, CAPAs).

Aufgaben

• Serve as QA contact for assigned API external manufacturing sites and foster collaboration.
• Review and approve manufacturing documentation to ensure cGMP compliance and product quality.
• Lead quality audits of external manufacturing partners to assess regulatory compliance.
• Oversee and approve critical quality events, investigations, and CAPAs with timely resolution.
• Collaborate with cross-functional teams to support tech transfers and continuous improvement at external sites.
• Monitor quality metrics and implement corrective actions for external manufacturers.
• Develop and maintain quality agreements with external partners.
• Support regulatory inspections and respond to inquiries related to external manufacturing.
• Maintain knowledge of cGMP regs (FDA/EMA) and industry best practices.

Kenntnisse

Quality Assurance

Auditing

cGMP knowledge

Regulatory liaison

Stakeholder collaboration

Ausbildung

Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or related

Jobbeschreibung

Eli Lilly and Company is seeking a Senior/Principal Associate QA API External Manufacturing to ensure quality and compliance of externally manufactured APIs in line with cGMP regulations. The role involves significant oversight and collaboration with external manufacturing partners.

Responsibilities include reviewing documentation, leading audits, managing deviations and CAPAs, and supporting tech transfers and regulatory interactions. Travel up to 25% may be required.