Sr. Principal Scientist - Quality Assurance

Eli Lilly and Company•Research Triangle Park, NC

38d

About The Position

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. 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. Position Overview: Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Sr. Principal Scientist to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. Position Description: The Quality Assurance Sr. Principal Scientist is a member of the Quality Assurance team who provides technical leadership and expertise for quality production support in the following areas: 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 the site inspection readiness program, supports the APR process, and advises lead investigators, functional leaders and site quality leader on production issues.

Requirements

Bachelor's Degree or equivalent work experience.
7 or more years in the pharmaceutical industry.
Demonstrated 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.
Demonstrated attention to detail and ability to maintain quality systems.
Previous experience leading or working effectively with a cross-functional group.
Demonstrated excellent interpersonal, written and oral communication skills.
Demonstrated strong technical aptitude and ability to train and mentor others.
Demonstrated decision making and problem-solving skills.
Demonstrated ability to organize and prioritize multiple tasks.

Nice To Haves

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

Responsibilities

Support the site in the development and execution of the site readiness plan with focus on supporting operations process and startup of new systems.
Lead, mentor, and coach QA Floor, Operations teams and Support Personnel on quality matters.
Provide back up 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.
Liaison with Lilly support groups and external partners to develop process knowledge, resolve or provide advice on product related issues.
Provides 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 in a positive fashion 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.

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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