Senior QA Lead – API External Manufacturing (Peptides)

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

Benefits offered by this job

Company bonus

401(k) plan

Pension plan

Vacation benefits

Medical coverage

Dental coverage

Vision coverage

Flexible benefits

Life insurance

Paid time off

Well-being programs

Job summary

Lilly's Active Pharmaceutical Ingredient External Manufacturing (API-EM) organization oversees the production of large molecule and biologics APIs at contract manufacturing sites worldwide. This role provides QA oversight of external API manufacturing, including batch disposition, deviation management, change control, and CAPA-driven improvements.

The qualified candidate will conduct audits, review quality documentation, manage the QA shop floor operations for GMP, support tech transfers and new

Qualifications

• Bachelor's degree in chemistry, biochemistry, pharmacy, chemical engineering or related science.
• 5+ years in pharma/biopharma QA, preferably API manufacturing and external supply.
• Experience supporting GMP manufacturing on a QA shop floor.
• Strong knowledge of cGMP regulations and global quality requirements.
• Ability to travel domestically and internationally as needed.

Responsibilities

• Provide QA oversight of external API manufacturing, including batch disposition, deviation management, and change control.
• Conduct and support audits to ensure compliance with cGMP regulations and Lilly quality standards.
• Review and approve quality documentation, batch records, validations, stability data, and analytical methods.
• Collaborate with internal functions and external manufacturers to resolve quality issues and drive improvements.
• Support new product introductions, technology transfers, and quality agreement management.
• Lead investigations of quality events, deviations, and OOS, identifying root causes and CAPAs.

Skills

QA oversight

cGMP knowledge

External API manufacturing

Audits

CAPA

Deviations

Analytical methods

Travel flexibility

Education

Bachelor's degree in Chemistry/ Biochemistry/ Pharmacy/ Chemical Engineering

Job description

Lilly's Active Pharmaceutical Ingredient External Manufacturing (API-EM) organization oversees the production of large molecule and biologics APIs at contract manufacturing sites worldwide. This role provides QA oversight of external API manufacturing, including batch disposition, deviation management, change control, and CAPA-driven improvements.

The qualified candidate will conduct audits, review quality documentation, manage the QA shop floor operations for GMP, support tech transfers and new