Sr. Principal Associate - GQA Advisor
Eli Lilly and Company
June 29, 2026
On-site
Indianapolis, IN
Operations
Sr. Principal Associate – GQA Advisor
Responsibilities
- Ensure processes/procedures comply with company requirements, regulations, and guidelines.
- Perform internal investigations (for-cause and HR-quality related) supporting the HRQ program; support escalation, investigation, reconciliation, and trending of compliance investigations impacting Quality.
- Assess and investigate Quality-related deviations and applicable audits.
- Support triage discussions to assess potential quality impact; investigate and coordinate procedural escalation/documentation with cross-functional partners.
- Provide investigation guidance, including root-cause analysis to ensure consistency across sites (including human relations quality impact and potential conflict-of-interest cases).
- Conduct GxP audits and perform root-cause and trend investigations per GQA processes.
- Collaborate with Quality Culture, Data Integrity, and GMP Training teams to develop/deliver initiatives addressing common themes.
- Consult/collaborate to ensure required escalation and consistent execution of GQS104.
- Attend training/conferences and share learnings; stay current on GxP trends and regulatory interpretations.
- Participate in projects supporting GxP compliance and continuous improvement.
Minimum Requirements / Skills
- BS in Pharmacy, Chemistry, Biology, Engineering, Microbiology, or related field; 10+ years relevant experience including Quality Assurance or Quality Control.
- Strong Quality Assurance/GxP compliance knowledge; ability to influence, negotiate, and investigate.
- Demonstrated ability to perform GxP audits across modalities (e.g., paraenteral).
- Critical thinking, root-cause analysis, complex investigation management.
- Excellent oral/written communication and presentation skills.
- Ability to interpret/apply standards and solve problems.
- Ability to work independently and in a team.
Education
- 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).
- Location: Indianapolis Corporate Center or another Lilly US site.
Compensation/Benefits (as stated)
- Anticipated wage: $65,250–$169,400; may be eligible for a company bonus.
- Comprehensive benefits include 401(k) and pension, medical/dental/vision, life/disability, paid time off, and well-being benefits.
Application Instructions
- Internal applicants: current supervisor is notified; discuss the opportunity with your supervisor prior to applying.
Responsibilities
- Ensure processes/procedures comply with company requirements, regulations, and guidelines.
- Perform internal investigations (for-cause and HR-quality related) supporting the HRQ program; support escalation, investigation, reconciliation, and trending of compliance investigations impacting Quality.
- Assess and investigate Quality-related deviations and applicable audits.
- Support triage discussions to assess potential quality impact; investigate and coordinate procedural escalation/documentation with cross-functional partners.
- Provide investigation guidance, including root-cause analysis to ensure consistency across sites (including human relations quality impact and potential conflict-of-interest cases).
- Conduct GxP audits and perform root-cause and trend investigations per GQA processes.
- Collaborate with Quality Culture, Data Integrity, and GMP Training teams to develop/deliver initiatives addressing common themes.
- Consult/collaborate to ensure required escalation and consistent execution of GQS104.
- Attend training/conferences and share learnings; stay current on GxP trends and regulatory interpretations.
- Participate in projects supporting GxP compliance and continuous improvement.
Minimum Requirements / Skills
- BS in Pharmacy, Chemistry, Biology, Engineering, Microbiology, or related field; 10+ years relevant experience including Quality Assurance or Quality Control.
- Strong Quality Assurance/GxP compliance knowledge; ability to influence, negotiate, and investigate.
- Demonstrated ability to perform GxP audits across modalities (e.g., paraenteral).
- Critical thinking, root-cause analysis, complex investigation management.
- Excellent oral/written communication and presentation skills.
- Ability to interpret/apply standards and solve problems.
- Ability to work independently and in a team.
Education
- 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).
- Location: Indianapolis Corporate Center or another Lilly US site.
Compensation/Benefits (as stated)
- Anticipated wage: $65,250–$169,400; may be eligible for a company bonus.
- Comprehensive benefits include 401(k) and pension, medical/dental/vision, life/disability, paid time off, and well-being benefits.
Application Instructions
- Internal applicants: current supervisor is notified; discuss the opportunity with your supervisor prior to applying.