Principal/Senior Principal/Advisor - QA Flow Mentor IAPI

QA Flow Mentor

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 over 50,000 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. This is hard, urgent, selfless workbut it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The QA Flow Mentor provides technical leadership and expertise for production operations in the areas of: coaching and mentoring front line process QA reps, developing and sustaining process knowledge, process and equipment support, process optimization and continuous improvement, developing and sustaining quality systems, and adherence to business systems.

Key objectives/deliverables include:

• Coach and mentor front-line QA reps
• Lead qualification efforts for new frontline QA reps
• Coach and mentor front-line process QA reps in aspects of fundamental QA support including process understanding (both theoretical and practical), problem solving, project management, and deviation resolution
• Related experiences with troubleshooting bio-purification and traditional unit operations such as chromatography, tangential flow filtration, fermentation, homogenization, evaporation, mixing, and distillation
• Champion the application of statistical thinking and use of data to monitor process performance and make risk-based QA decisions
• Support and peer review root cause analysis around operational events
• Promote and peer review documentation of learning points, gap assessments, and event investigations
• Provide technical support to non-routine (e.g., deviation) investigations
• Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives
• Provide process and equipment support
• Identify systemic issues affecting production (deviations, cycle time delays, etc.)
• Lead or participate in root cause analysis and countermeasure development and implementation for major compliance or throughput event investigations
• Provide back up and shutdown support for front-line QA reps
• Act as the liaison between central services groups (e.g., Q Engineering) and the process teams and participate/lead implementation of central services initiatives (as needed/appropriate)
• Participate in the APR process
• Process optimization & continuous improvement
• Review, identify and drive alignment of QA systems across IAPI
• Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation
• Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives
• Collaborate with key support groups around the development of process knowledge and a common process improvement agenda
• Provide quality oversight/approval of periodic reviews for direct impact systems to ensure constant state of qualification
• Provide quality oversight during development of equipment and process system user requirements and related design review/qualification documentation to ensure that equipment/systems are appropriate for the intended purpose and comply with applicable global quality standards/engineering standards
• Provide independent peer input/review of technical activities
• Adherence to QA/business systems
• Provide support to the QA organization for deviation reduction and backlog prevention initiatives
• Chair the deviation review board/change review board
• Analyze process/unit team metrics for awareness and identification of potential improvement opportunities:
• Deviation cycle time
• Event root causes
• Overdue CAPA items

Basic requirements include:

• Bachelor's required in 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
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Additional preferences include:

• Technical knowledge of chemical processing and process equipment
• Ability to function in a team environment as a leader and as a member of teams
• Effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences
• Knowledge of protein chemistry & process/cleaning validation
• Ability to partner/network outside the IAPI site and demonstrated participation in inspection readiness/continuous improvement initiatives
• Statistical thinking
• Technical knowledge of chemical processing and process equipment
• Ability to function in a team environment as a leader and as a member of teams
• Effectively manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences
• Knowledge of protein chemistry & process/cleaning validation
• Ability to partner/network outside the IAPI site and demonstrated participation in inspection readiness/continuous improvement initiatives
• Advocate for training and knowledge sharing
• Communication skills
• Develop and implement innovative approaches to problems
• Successful application of root cause analysis and systematic problem solving
• Strong computer skills in a variety of software packages (Visio, Trackwise, Veeva, MS Project)

Other information includes:

• The normal schedule for this position is Monday-Friday, 8 hours/day. However, emergency situations may require additional support beyond this normal schedule.
• Little to no travel is required with this position.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.

This role is located in Indianapolis, IN and requires the individual to be onsite.