QA - Compliance CAPA Lead

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 35,000 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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

The QA Compliance CAPA Lead serves as the site lead overseeing the RTP CAPA program which is part of the overall Quality Management System (QMS) which enables the organization to provide safe and effective products and to meet customer expectations and regulatory requirements.

The QA Compliance CAPA Lead is responsible for collecting and analyzing information to identify actual and potential product and quality problems, work with RTP Site Quality Lead Team to take appropriate and effective corrective and preventive actions and to verify and validate the effectiveness of those CAPA.  Lead the site in driving product and process improvement and enhanced product and process understanding.

Key Objectives/Deliverables:

• Facilitate the RTP Site Deviation and CAPA review board, providing board leadership to drive complete root cause investigations and assigning corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence.
• Create and maintain the RTP CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems.
• Compile and present CAPA program health metrics to the RTP Site Quality Lead Team and Site Flow Teams with proposed actions.
• Act as Site Instructor for Deviation Management and associated TrackWise 1000 Observation Module roles.
• Authors, periodic reviews, and acts as Subject Matter Expert for RTP site CAPA and Deviation Management procedures.
• Support and initiate TrackWise Trend, RCI’s, Tasks or other technical investigations, as applicable.
• Engage site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding.

Minimum Requirements:

• At least 5 years working in the pharmaceutical or medical device industry in QA roles.
• Proficiency with GMP computer systems including CAPA systems, and Document Control systems.
• Technical knowledge of quality systems
• Previous process leadership, people influencer experience
• Knowledge of regulatory requirements (e.g., cGMP, 21CFR820, ISO13485, Canadian MDR)
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Demonstrated strong technical writing skills.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

• Previous regulatory inspection readiness and inspection execution experience.

• Ability to work 8-hour days – Monday through Friday
• Ability to work overtime as required

Additional Preferences:

• Ability to compile data and metrics in reports understandable by management and business partners
• Attention to detail, self-management, problem solving; mentoring.
• Previous experience with CAPA management systems including TrackWise

Education Requirements:

• Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.

Other Information:

• The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

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