Senior QA Lead, External API Manufacturing (Peptides)

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

Benefits offered by this job

Company bonus

Comprehensive benefits package

Job summary

Lilly in Indianapolis, IN is seeking an experienced Quality Assurance professional to oversee external API manufacturing operations on-site at Indianapolis or Durham. You will ensure cGMP compliance, review master records, and lead audits of third-party sites.

Role emphasizes collaboration with Supply Chain, Regulatory Affairs, and technical services, plus mentoring junior QA staff. Domestic/international travel may be required.

Qualifications

• Bachelor's degree in a relevant scientific discipline is required.
• Minimum 5 years in Quality Assurance within pharma/biopharma.
• Experience with external API manufacturing and auditing.
• Understanding of global pharmacopeial requirements.

Responsibilities

• Lead QA oversight for external API manufacturing sites and batch record review.
• Audit external sites for cGMP compliance and regulatory expectations.
• Review and approve manufacturing documents and change controls.
• Collaborate with cross-functional teams to resolve quality issues and drive improvements.

Skills

Quality Assurance

cGMP

Auditing

Regulatory liaison

Education

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

Tools

Veeva

Job description

Lilly in Indianapolis, IN is seeking an experienced Quality Assurance professional to oversee external API manufacturing operations on-site at Indianapolis or Durham. You will ensure cGMP compliance, review master records, and lead audits of third-party sites.

Role emphasizes collaboration with Supply Chain, Regulatory Affairs, and technical services, plus mentoring junior QA staff. Domestic/international travel may be required.