Senior Principal QA Lead — Analytical Quality (GMP)

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

Benefits offered by this job

Company bonus

401(k) plan

Health insurance

Pension

Vacation benefits

Job summary

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance to ensure laboratory activities at the Lilly Medicine Foundry adhere to global quality standards and cGMP requirements.

The role provides quality oversight for GMP testing, method qualification, and analytical development while supporting external partner labs. It involves establishing and maintaining the quality management system for this area, with emphasis on data integrity and continuous process improvement as the

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field with at least 5 years of technical laboratory experience.
• Quality assurance experience in the pharmaceutical industry preferred.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Provide quality oversight in analytical testing, including qualification of new contract labs and investigations.
• Oversee method verification, qualification, and validation activities.
• Ensure quality systems are in place and actively used; drive quality improvement initiatives.
• Evaluate potential impact of incidents on material quality or data integrity.
• Review GMP documentation and obtain appropriate expert approvals.
• Consult on quality-related issues and network with Lilly quality organizations.

Skills

GMP knowledge

Analytical testing

Quality assurance

Laboratory experience

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field

Job description

Lilly is seeking a Sr. Principal Associate for Analytical Quality Assurance to ensure laboratory activities at the Lilly Medicine Foundry adhere to global quality standards and cGMP requirements.

The role provides quality oversight for GMP testing, method qualification, and analytical development while supporting external partner labs. It involves establishing and maintaining the quality management system for this area, with emphasis on data integrity and continuous process improvement as the