Sr. Principal Scientist - Quality Assurance

Sr. Principal Scientist - Quality Assurance

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, improve the understanding and management of disease, and give back through philanthropy and volunteerism.

Lilly is actively growing its manufacturing footprint globally and is looking for an experienced Quality Assurance Sr. Principal Scientist to support our Research Triangle Park facility. This is an outstanding opportunity to contribute to new manufacturing investments and pioneering technologies.

The Quality Assurance Sr. Principal Scientist is a member of the QA team who provides technical leadership and expertise for quality production support. Responsibilities include coaching and mentoring QA floor teams, developing and sustaining process knowledge, process and equipment support, process optimization and continuous improvement, sustaining quality management systems, and adherence to business processes. The Sr. Principal Scientist also participates in regulatory inspections, collaborates in site inspection readiness, supports the APR process, and advises investigators, functional leaders, and the site quality leader on production issues.

• Support site readiness plan development and execution focusing on operations, processes, and startup of new systems
• Lead, mentor, and coach QA floor, Operations teams, and support personnel on quality matters
• Provide backup and shutdown support for QA floor reps as needed
• Lead or participate in non‑routine investigations, root cause analysis, and countermeasure development and implementation for major compliance or throughput event investigations
• Provide process and equipment support through identification of systemic issues affecting production (deviations, cycle time delays, etc.)
• Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives
• Support development and technical analysis for large‑scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation
• Liaise with Lilly support groups and external partners to develop process knowledge, resolve or provide advice on product‑related issues
• Provide guidance in operational areas to ensure robust quality systems and GMP compliance (documentation review, gap assessments, and deviations)
• Perform reviews of event documentation for technical accuracy and compliance
• Work within cross‑functional teams to implement QA objectives and deliver on business plan and quality objectives
• Participate in self‑led inspections and provide support during internal / external regulatory inspections
• Analyze process team metrics for awareness and identification of potential improvement opportunities
• Provide support to the QA organization for deviation reduction and backlog prevention initiatives
• Support APR program

• Bachelor’s Degree or equivalent work experience
• 7 or more years in the pharmaceutical industry
• Strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements
• Previous regulatory inspection readiness and inspection execution experience
• Attention to detail and ability to maintain quality systems
• Experience leading or working effectively with a cross‑functional group
• Excellent interpersonal, written and oral communication skills
• Strong technical aptitude and ability to train and mentor others
• Decision‑making and problem‑solving skills
• Ability to organize and prioritize multiple tasks

• Experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.
• Experience with Manufacturing Execution Systems and electronic batch release
• CQM, CQE, or CQA certification from the American Society for Quality (ASQ)
• Experience with Trackwise, Veeva, MODA