Sr. Principal Associate for Analytical Quality Assurance - Foundry
Eli Lilly and Company
August 24, 2026
On-site
Indianapolis, IN
Operations
Organization/Position Overview
- Sr. Principal Associate for Analytical Quality Assurance provides quality oversight for laboratory activities in the Lilly Medicine Foundry and with external partners, ensuring cGMP compliance and data integrity; supports quality management system establishment for GMP testing/analytical development.
Responsibilities
- Provide quality oversight in Analytical testing: molecule/modality support, qualification of new contract labs, audit support, quality system ownership, lead analytical compliance projects, and review quality documentation (deviations, change records).
- Provide quality oversight of method verification, qualification, and validation.
- Ensure quality systems are in place and used; facilitate quality improvement and implementation of new quality standards.
- Evaluate impact of incidents on material quality or data integrity.
- Ensure investigations for deviations, stability failures, and OOS results; review/approve related documentation.
- Perform QA review/approval/rejection of GMP documentation and ensure expert review.
- Consult on quality-related issues; network with Lilly quality organizations and share best practices.
- Promote quality culture and oversee quality presence in laboratory areas.
- Identify and lead process improvement projects impacting multiple business areas.
Basic Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field + minimum 5 years technical laboratory experience; pharmaceutical QA experience preferred.
- Experience in fast-paced environments; large-scale capital project delivery experience highly desirable.
- Strong knowledge of analytical method development/validation.
- Strong knowledge of GMP expectations and quality management systems.
- Minimum 5 years laboratory/analytical testing experience.
- Authorized to work in the United States full-time; no visa sponsorship.
Additional Preferences
- Ability to manage dynamic environments; influence complex technical decisions; implement innovative processes with quality/acceleration.
- Networking experience; coaching/mentorship; relationship building and influence.
- Strong communication; prioritize issues and implement solutions.
- High learning agility; drive KPIs/metrics/data analysis.
Other Information
- Initial location: Parkwood West, Carmel, Indiana.
- Permanent location: new Lilly Medicines Foundry, Lebanon, Indiana.
- Sr. Principal Associate for Analytical Quality Assurance provides quality oversight for laboratory activities in the Lilly Medicine Foundry and with external partners, ensuring cGMP compliance and data integrity; supports quality management system establishment for GMP testing/analytical development.
Responsibilities
- Provide quality oversight in Analytical testing: molecule/modality support, qualification of new contract labs, audit support, quality system ownership, lead analytical compliance projects, and review quality documentation (deviations, change records).
- Provide quality oversight of method verification, qualification, and validation.
- Ensure quality systems are in place and used; facilitate quality improvement and implementation of new quality standards.
- Evaluate impact of incidents on material quality or data integrity.
- Ensure investigations for deviations, stability failures, and OOS results; review/approve related documentation.
- Perform QA review/approval/rejection of GMP documentation and ensure expert review.
- Consult on quality-related issues; network with Lilly quality organizations and share best practices.
- Promote quality culture and oversee quality presence in laboratory areas.
- Identify and lead process improvement projects impacting multiple business areas.
Basic Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field + minimum 5 years technical laboratory experience; pharmaceutical QA experience preferred.
- Experience in fast-paced environments; large-scale capital project delivery experience highly desirable.
- Strong knowledge of analytical method development/validation.
- Strong knowledge of GMP expectations and quality management systems.
- Minimum 5 years laboratory/analytical testing experience.
- Authorized to work in the United States full-time; no visa sponsorship.
Additional Preferences
- Ability to manage dynamic environments; influence complex technical decisions; implement innovative processes with quality/acceleration.
- Networking experience; coaching/mentorship; relationship building and influence.
- Strong communication; prioritize issues and implement solutions.
- High learning agility; drive KPIs/metrics/data analysis.
Other Information
- Initial location: Parkwood West, Carmel, Indiana.
- Permanent location: new Lilly Medicines Foundry, Lebanon, Indiana.