Sr. Principal Associate - GQA Advisor

Sr. Principal Associate – GQA Advisor

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters.

Headquartered in Indianapolis, Indiana, our 50,000‑plus employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve.

• Manage sensitive information in accordance with Lilly Policies and support triage discussions to assess potential impact to quality. Investigate investigations accordingly and collaborate with cross‑functional partners to ensure procedural escalation and documentation requirements are met.
• Provide investigation guidance, conduct root‑cause analysis, and ensure consistency across sites for quality‑related investigations associated with human relations or potential conflicts of interest in the Quality unit.
• Conduct audits, root‑cause and trend investigations for GQA per established processes, and collaborate with the Quality Culture, Data Integrity, and GMP Training teams to identify, develop, and deliver initiatives addressing common themes.
• Consult with cross‑functional partners to ensure investigations with potential human relations quality impact are escalated per program requirements and drive consistent execution of GQS
  104. Consult with GQA members for broader quality and compliance gaps, deviations, and trending.
• Attend training courses, conferences, or association meetings to continue gaining knowledge and share such information with the team or company to increase awareness and train others. Stay aware of current industry trends and regulatory agency interpretations of GxP and other relevant requirements.
• Participate in projects that support or enhance GxP Compliance and continuous improvement.

• Minimum Bachelor’s Degree in Pharmacy, Chemistry, Biology, Engineering, Microbiology, or other technical field of study.
• Minimum 10 years relevant industry experience in Quality Assurance or Quality Control, including experience in a GxP function.
• Experience performing GxP audits for various modalities (e.g., parenteral). Demonstrated critical thinking, root‑cause analysis, and complex investigation management.
• Strong compliance knowledge with ability to influence others, negotiate, and investigate.
• Excellent oral and written communication and presentation skills. Ability to communicate and deliver constructive feedback.
• Ability to interpret and apply standards to different situations by understanding subject needs and applying good problem‑solving skills.
• Ability to work independently and as part of a team with minimal supervision.

BA, BS, MS, or Ph.D. in a technical field, such as Biology, Chemistry, Engineering, Pharmacy, or Microbiology.

• Must be able to work in a GxP environment.
• Must be able to travel < 10–50%, including international travel.
• Position located at Indianapolis Corporate Center or another Lilly U.S. site.

• Competitive pay ranging from $65,250 to $169,400 annually.
• 3% 401(k) match, defined benefit pension, and retiree medical coverage.
• Medical, dental, vision, and prescription drug coverage options.
• Life and disability insurance. Paid time off including personal illness, caregiver, bereavement, holidays, and annual vacation.
• Well‑being programs: mental health support, fitness membership, health coaching, concierge services.
• Employee resource groups and inclusive culture.

Lilly is an equal opportunity employer. We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status for the B or S paths or for levels M1–M2 or P1–P4.