Senior QA Lead, API External Manufacturing

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

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly in Indianapolis is seeking an experienced Quality Assurance professional to oversee external API manufacturing, ensuring compliance with cGMP and regulatory requirements for products produced by third-party partners.

You will review master batch records, validation data, and stability information, and collaborate across functions to resolve quality issues, lead audits, and guide CAPA programs. Travel to external sites may be required.

Qualifications

• Bachelor's degree in a related scientific field.
• Minimum 5 years of QA experience in pharma with API external supply.
• Experience with cGMP regulations and auditing external sites.
• Experience with quality management systems (e.g., Veeva).

Responsibilities

• Oversee quality aspects of external API manufacturing sites, including batch record review, disposition, deviations, and change control.
• Conduct and/or participate in quality audits of external sites to assess cGMP compliance and QA standards.
• Review and approve quality documents (batch records, validation protocols, reports, stability data).
• Collaborate with internal functions and external partners to resolve quality issues and drive improvements.
• Provide QA guidance during tech transfers and new product introductions.
• Develop and maintain quality agreements with external manufacturers.
• Investigate quality incidents and drive CAPAs.
• Represent Lilly's QA interests during regulatory inspections at external sites.
• Mentor junior QA staff.

Skills

Quality Assurance

cGMP knowledge

External manufacturing audits

Quality systems (Veeva)

Education

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

Tools

Veeva

Job description

Lilly in Indianapolis is seeking an experienced Quality Assurance professional to oversee external API manufacturing, ensuring compliance with cGMP and regulatory requirements for products produced by third-party partners.

You will review master batch records, validation data, and stability information, and collaborate across functions to resolve quality issues, lead audits, and guide CAPA programs. Travel to external sites may be required.