Senior Principal Analytical Quality Lead

Eli Lilly and Company; Lebanon (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

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

The role provides quality oversight for analytical method development, instrumentation qualification, and data integrity, coordinating with internal teams and external labs. Based in Indiana, it supports design, validation, and continuous improvement within a rapid-build environment.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field with 5+ years of laboratory experience.
• Strong knowledge of analytical method development and validation.
• Familiarity with current GMP expectations and quality management systems.
• Authorized to work in the United States on a full-time basis; Lilly does not provide visa sponsorship.

Responsibilities

• Provide quality oversight in analytical testing, including molecule and modality support, qualification of new contract labs, audit support, and quality system ownership.
• Oversee method verification, qualification, and validation activities.
• Ensure quality systems are in place and used; implement quality improvements and new standards.
• Evaluate potential impact of incidents on material quality or data integrity.
• Conduct investigations for deviations, stability failures, and out-of-spec results with documentation review.
• Perform QA review/approval of GMP documentation and ensure technical expert involvement.
• Be available for consultation on quality-related issues and share best practices across Lilly quality organizations.
• Promote a positive quality culture and lead process improvement projects affecting multiple areas.

Skills

QA experience

Analytical methods

Laboratory work

GMP knowledge

Quality systems

Education

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

Job description

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

The role provides quality oversight for analytical method development, instrumentation qualification, and data integrity, coordinating with internal teams and external labs. Based in Indiana, it supports design, validation, and continuous improvement within a rapid-build environment.