Sr. Principal/Advisor – QA – Flow Mentor – IAPI
Location: Indianapolis, Indiana, United States
Category: Manufacturing/Quality
Job Type: Full Time, Regular
Job Id: R-81080
Company Overview:
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, committed to improving lives through discovery, innovation, and compassion. Our employees work to bring life-changing medicines to people worldwide while contributing to community well-being through philanthropy and volunteerism.
Position Summary:
The QA Flow Mentor provides technical leadership and expertise in production operations by coaching and mentoring Front Line Process QA Reps, developing and sustaining process knowledge, supporting process and equipment, driving continuous improvement, maintaining quality systems, and adhering to business systems.
Key Objectives/Deliverables:
1. Coach and Mentor Front-Line QA Reps:
Lead qualification efforts for new frontline QA reps.
Coach and mentor QA reps on process understanding, problem-solving, project management, and deviation resolution.
Troubleshoot bio-purification and traditional unit operations (chromatography, tangential flow filtration, fermentation, homogenization, etc.).
Apply statistical thinking and data-driven decision-making.
Support and peer review root cause analysis and documentation of learning points and event investigations.
Provide technical support for non-routine investigations.
2. Provide Process & Equipment Support:
Identify systemic production issues (deviations, cycle time delays, etc.).
Lead or participate in root cause analysis and develop countermeasures.
Provide backup and shutdown support for QA reps.
Act as a liaison between central services groups and process teams.
Participate in the Annual Product Review (APR) process.
3. Process Optimization & Continuous Improvement:
Drive alignment of QA systems across IAPI.
Support large-scale initiatives such as productivity improvements and capacity development.
Identify continuous improvement opportunities and assist in prioritizing them.
Oversee the quality of Periodic Reviews for Direct Impact systems.
Provide quality oversight during the development of equipment and process system documentation.
4. Adherence to QA/Business Systems:
Support deviation reduction and backlog prevention initiatives.
Chair the Deviation Review Board/Change Review Board.
Analyze process/unit team metrics to identify improvement opportunities (Deviation Cycle Time, Event Root Causes, Overdue CAPA items).
Basic Requirements:
Bachelor’s degree (or equivalent experience) in a scientific/engineering discipline.
5+ years of work experience in a technical support area (e.g., Engineering, TS/MS).
2+ years of work experience in Quality Assurance.
Additional Preferences:
Strong statistical thinking and technical knowledge of chemical processing.
Ability to lead and collaborate effectively within a team environment.
Proven ability to manage and prioritize competing priorities.
Knowledge of protein chemistry, process/cleaning validation, and participation in inspection readiness/continuous improvement initiatives.
Strong communication skills with the ability to convey complex ideas.
Proficiency in software packages (Visio, Trackwise, MS Project, Excel).
Other Information:
Standard schedule: Monday-Friday, 8 hours/day.
Emergency situations may require additional support.
Little to no travel required.
Tasks involve entering manufacturing and laboratory areas, requiring appropriate PPE.
This role requires onsite presence in Indianapolis, IN.
Compensation and Benefits:
Salary Range: $63,000 - $162,800
Eligible for a company bonus based on individual and company performance.
Comprehensive benefits include 401(k), pension, medical, dental, vision, flexible spending accounts, life insurance, paid time off, and well-being programs.
Lilly is an equal opportunity employer and is committed to diversity, equity, and inclusion.
#WeAreLilly
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