Senior QA Lead - External API Manufacturing

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

Benefits offered by this job

Annual bonus

401(k) plan

Health, dental, vision benefits

Job summary

Eli Lilly and Company is seeking a Senior / Principal Associate QA API External Manufacturing to ensure the quality and compliance of externally manufactured APIs in line with cGMP and company standards. You will oversee QA activities with external partners and drive continual improvement across the supply chain.

The role requires strong QA expertise in API manufacturing, auditing experience, and the ability to collaborate with regulatory and cross-functional teams.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related discipline.
• 5+ years (Senior Associate) or 8+ years (Principal Associate) of QA experience in pharmaceutical/biopharmaceutical API manufacturing and external supply quality.
• In-depth knowledge of cGMP regulations (e.g., 21 CFR Part 210/211, ICH Q7) and international quality standards.

Responsibilities

• Serve as the primary QA point of contact for assigned API external manufacturing sites, fostering collaboration.
• Review and approve manufacturing documentation to ensure cGMP compliance and product quality.
• Lead QA audits of external manufacturing partners for regulatory compliance and quality systems.
• Oversee and approve critical quality events, deviations, investigations, and CAPAs.
• Collaborate with cross-functional teams to support new product introductions and tech transfers.

Skills

Quality Assurance

cGMP

Auditing

Regulatory Compliance

Education

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

Tools

CAPA system

Regulatory databases

Job description

Eli Lilly and Company is seeking a Senior / Principal Associate QA API External Manufacturing to ensure the quality and compliance of externally manufactured APIs in line with cGMP and company standards. You will oversee QA activities with external partners and drive continual improvement across the supply chain.

The role requires strong QA expertise in API manufacturing, auditing experience, and the ability to collaborate with regulatory and cross-functional teams.