Sr Principal-QA-API

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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 & Equipment Support, Process Optimization & Continuous Improvement, Developing and Sustaining Quality Systems, and Adherence to Business Systems.

Key Objectives/Deliverables:

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 & 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. Perform reviews of event documentation for technical accuracy and compliance.
• 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:

• 5 plus years of work experience in a technical support area (e.g., Engineering, TS/MS).
• 2 plus years of work experience in Quality Assurance

Additional Preferences:

• Statistical thinking
• Advocate for training and knowledge sharing
• Communication skills
• Develop and implement innovative approaches to problems
• 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.
• Successful application of root cause analysis and systematic problem solving
• Strong computer skills in a variety of software packages (Visio, Trackwise, MS Project, Excel)

Other Information:

• 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.
• Must complete learning plan for QA Flow Mentor.
• No certifications required.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Sr. Principal/Advisor level is considered equivalent to QA Associate Director for the purposes of Quality Assurance Approval

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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