Senior QA Lead – API External Manufacturing (Peptides)

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

Benefits offered by this job

Company bonus

401(k) plan

Medical benefits

Job summary

Lilly, headquartered in Indianapolis, IN, seeks a Quality Assurance professional to oversee API External Manufacturing operations at on-site sites in Indianapolis, IN or Durham, NC. The role ensures regulatory compliance, audits, and robust QA support for third-party manufacturing partners.

The position requires 5+ years in QA within pharma, cGMP experience, auditing of external sites, and travel as needed. Competitive compensation and benefits accompany this full-time role.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering or related science.
• Minimum 5 years of QA experience in pharma/biopharma with focus on API manufacturing and external supply.
• Experience with cGMP regulations (FDA, EMA, HPRA) and pharmacopeial requirements.
• Experience auditing external manufacturing sites.
• Experience with quality management systems (e.g., Veeva).
• Willingness to travel domestically and internationally to external sites.

Responsibilities

• Lead and manage quality aspects of external API manufacturing sites including batch record review, disposition, deviation management, and change control.
• Conduct and/or participate in quality audits of external sites to assess compliance with cGMP and Lilly standards.
• Review and approve quality-related documents (master batch records, validation protocols, reports, stability data, assays).
• Collaborate with internal teams and external partners to resolve quality issues and drive improvements.
• Provide QA guidance during new product introductions and technology transfers to external manufacturers.
• Develop, implement, and maintain quality agreements with external orgs.
• Investigate quality incidents, determine root causes, and implement CAPAs.
• Represent Lilly's quality interests during regulatory inspections at external sites.
• Mentor junior QA associates.

Skills

Quality Assurance

Audit experience

cGMP knowledge

External manufacturing

Regulatory compliance

Education

Bachelor's degree in Chemistry

Tools

Veeva

Job description

Lilly, headquartered in Indianapolis, IN, seeks a Quality Assurance professional to oversee API External Manufacturing operations at on-site sites in Indianapolis, IN or Durham, NC. The role ensures regulatory compliance, audits, and robust QA support for third-party manufacturing partners.

The position requires 5+ years in QA within pharma, cGMP experience, auditing of external sites, and travel as needed. Competitive compensation and benefits accompany this full-time role.