Senior/Principal QA - API External Manufacturing

BioSpace; Indianapolis (IN); Presencial; USD 65.000 - 169.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance and death benefits

Well-being benefits

Descripción de la vacante

Eli Lilly and Company in Indianapolis seeks a Senior / Principal Associate QA API External Manufacturing to ensure quality and compliance of externally manufactured Active Pharmaceutical Ingredients (APIs) in accordance with cGMP regulations and company standards. This role involves oversight and collaboration with external manufacturing partners.

The role requires a Bachelor’s degree in a scientific discipline and 5–8 years of QA/API experience, with travel up to 25%.

Formación

• Bachelor's degree in a scientific discipline (Chemistry/Pharmacy/Engineering) is required.
• 5+ years QA experience in pharma/biopharma with focus on APIs; 8 years for Principal role.
• Strong knowledge of cGMPs (FDA/EMA) and international standards.

Responsabilidades

• Serve as QA contact for assigned API external sites and maintain partnerships.
• Review/approve master batch records, deviations, investigations, CAPAs, change controls, and OOS reports for cGMP compliance.
• Lead QA audits of external manufacturers to assess regulatory compliance and internal quality systems.
• Oversee approvals of quality events and ensure timely, effective resolutions.
• Collaborate with Supply Chain, Regulatory Affairs, and Technical Services on tech transfers and new product introductions.
• Monitor quality metrics at external manufacturers and drive corrective actions.
• Develop and maintain quality agreements with external partners.
• Support regulatory inspections and responses related to external manufacturing.
• Maintain knowledge of current cGMP regulations and industry best practices.

Conocimientos

Quality Assurance

cGMP knowledge

Auditing

Regulatory compliance

Analytical testing

Communication skills

Educación

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

Descripción del empleo

Eli Lilly and Company in Indianapolis seeks a Senior / Principal Associate QA API External Manufacturing to ensure quality and compliance of externally manufactured Active Pharmaceutical Ingredients (APIs) in accordance with cGMP regulations and company standards. This role involves oversight and collaboration with external manufacturing partners.

The role requires a Bachelor’s degree in a scientific discipline and 5–8 years of QA/API experience, with travel up to 25%.