Senior Principal Associate – Analytical Quality Assurance

Eli Lilly and Company

Sr. Principal Associate providing quality oversight in analytical testing for Lilly's Medicine Foundry.

Posted 5/7/2026full-timeIndianapolis • 🇺🇸 United StatesSenior💰 $65,250 - $169,400 per yearWebsite

About the role

Key responsibilities & impact

Provide quality oversight in Analytical testing, namely: molecule and modality support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records)
Provide quality oversight of method verification, qualification, and validation activities
Ensure that appropriate quality systems are in place and are being utilized
Facilitate quality improvement initiatives, and the implementation of new quality standards
When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data
Ensure appropriate investigations are conducted for deviations, stability failures and out of specification (OOS) results
Review and approval of the corresponding documentation
Perform Quality Assurance review and/or approval/rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred
Be available for consultation on quality-related issues as needed
Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices
Promote a positive quality culture and oversee quality presence in the respective laboratory areas
Identify and lead process improvement projects impacting multiple business areas

Requirements

What you’ll need

Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field with a minimum of 5 years technical laboratory experience
Quality assurance experience in the pharmaceutical industry, preferred
Relevant industry experience in highly paced working environments
Relevant experience of working on large-scale capital project deliveries is highly desirable
Strong knowledge of analytical method development and validation
Strong knowledge of the current GMP expectations and application of quality management systems in execution
Minimum 5 yrs of experience in laboratories and analytical testing
Qualified applicants must be authorized to work in the United States on a full-time basis

Benefits

Comp & perks

eligibility to participate in a company-sponsored 401(k)
pension
vacation benefits
eligibility for medical, dental, vision and prescription drug benefits
flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
life insurance and death benefits
certain time off and leave of absence benefits
well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

analytical testingmethod verificationqualificationvalidationquality assuranceGMP documentationquality management systemsanalytical method developmentquality improvement initiativesprocess improvement

Soft Skills

quality oversightconsultationnetworkingleadershipcommunicationproblem-solvingorganizational skillsattention to detailcollaborationpositive quality culture