Sr. Principal Associate - GQA Advisor
Eli Lilly and Company
August 26, 2026
On-site
Indianapolis, IN
Operations
Sr. Principal Associate – GQA Advisor (Global Quality Auditing)
Key Objectives/Deliverables
- Assure quality processes and procedures meet company requirements, current regulations, and guidelines.
- Perform internal investigations (for-cause and HR quality-related) in support of the HRQ program; support escalation, investigation, reconciliation, and trending of compliance investigations.
- Assist with assessment and investigation of quality-related deviations and applicable audits.
- Manage sensitive information per Lilly policies.
- Support triage discussions to assess potential quality impact; investigate and collaborate with cross-functional partners to meet escalation and documentation requirements.
- Provide investigation guidance and conduct root cause analysis for consistency across sites, including human relations quality impact and potential conflict-of-interest situations.
- Conduct audits, root cause, and trend investigations for GQA per established processes.
- Collaborate with Quality Culture, Data Integrity, and GMP Training teams to identify/develop/deliver initiatives to address common themes.
- Consult with cross-functional partners to ensure investigations with potential human relations quality impact are escalated per program requirements (GQS104) and drive consistent execution.
- Attend training/conferences/meetings; share learning to increase awareness.
- Stay current on industry trends and regulatory interpretation of GxP.
- Participate in projects supporting GxP compliance and continuous improvement.
Minimum Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering Microbiology, or other technical field; 10+ years relevant industry experience including Quality Assurance or Quality Control.
- Experience in Quality Assurance or GxP with strong compliance knowledge; ability to influence, negotiate, and investigate.
- Demonstrated ability to perform GxP audits for various modalities (including, but not limited to, paraenteral).
- Critical thinking, root cause analysis, and complex investigation management experience.
- Excellent oral and written communication and presentation skills.
- Ability to interpret/apply standards and solve problems.
- Ability to work independently and in a team with minimal supervision.
Education Requirements
- BA, BS, MS, or Ph.D. in a technical field (e.g., Biology, Chemistry, Engineering, Pharmacy, Microbiology).
Other Information
- Must be able to work in a GxP environment.
- Travel <10–50% including international travel.
- Position located at Indianapolis Corporate Center or another Lilly US site.
- Internal applicants: current supervisor is notified; discuss opportunity with supervisor prior to applying.
Key Objectives/Deliverables
- Assure quality processes and procedures meet company requirements, current regulations, and guidelines.
- Perform internal investigations (for-cause and HR quality-related) in support of the HRQ program; support escalation, investigation, reconciliation, and trending of compliance investigations.
- Assist with assessment and investigation of quality-related deviations and applicable audits.
- Manage sensitive information per Lilly policies.
- Support triage discussions to assess potential quality impact; investigate and collaborate with cross-functional partners to meet escalation and documentation requirements.
- Provide investigation guidance and conduct root cause analysis for consistency across sites, including human relations quality impact and potential conflict-of-interest situations.
- Conduct audits, root cause, and trend investigations for GQA per established processes.
- Collaborate with Quality Culture, Data Integrity, and GMP Training teams to identify/develop/deliver initiatives to address common themes.
- Consult with cross-functional partners to ensure investigations with potential human relations quality impact are escalated per program requirements (GQS104) and drive consistent execution.
- Attend training/conferences/meetings; share learning to increase awareness.
- Stay current on industry trends and regulatory interpretation of GxP.
- Participate in projects supporting GxP compliance and continuous improvement.
Minimum Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering Microbiology, or other technical field; 10+ years relevant industry experience including Quality Assurance or Quality Control.
- Experience in Quality Assurance or GxP with strong compliance knowledge; ability to influence, negotiate, and investigate.
- Demonstrated ability to perform GxP audits for various modalities (including, but not limited to, paraenteral).
- Critical thinking, root cause analysis, and complex investigation management experience.
- Excellent oral and written communication and presentation skills.
- Ability to interpret/apply standards and solve problems.
- Ability to work independently and in a team with minimal supervision.
Education Requirements
- BA, BS, MS, or Ph.D. in a technical field (e.g., Biology, Chemistry, Engineering, Pharmacy, Microbiology).
Other Information
- Must be able to work in a GxP environment.
- Travel <10–50% including international travel.
- Position located at Indianapolis Corporate Center or another Lilly US site.
- Internal applicants: current supervisor is notified; discuss opportunity with supervisor prior to applying.