Lilly QA Compliance CAPA Lead in Concord, North Carolina
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.
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!
The QA Compliance CAPA Lead serves as the site lead overseeing the Concord 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.
Working with the Site Quality Lead Team to take appropriate and effective corrective and preventive actionswhilemonitoringfor CAPA effectiveness.
Lead the site in driving product and process improvement and enhanced product and process understanding.
Program ownership for the Deviation and Change Management Quality Systems.
Facilitate Site CAPA review board, providing board leadership to drive complete root cause investigations and assigning corrective and preventative actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence.
Create and maintain the Concord CAPA program, through working cross-functionally with all area/function owners to include data sources that identify potential problems.
Compile, monitor, trend and present CAPA program health metrics to Site Quality Lead Team and Site Flow Teams with proposed actions.
Program Owner and Site Instructor for Deviation and Change Management Quality Systems including ensuring process compliance through the development of comprehensive procedures, work instructions, personnel qualification, and other process related documentation.
Support and initiate Trackwise Trend, Root Cause Investigations, Tasks, or other technical investigations, as applicable
Supports process improvement using a variety of Quality and Continuous Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, etc.
Requirements (Education, Experience, Training):
Bachelor’s degree in a science, engineering, or pharmaceutical related field of study or equivalent industry experience.
At least 5 years working in the pharmaceutical or medical device industry in QA roles.
Technical knowledge of quality systems
Previous process leadership, people influencer experience
Proficiency with cGMP computer systems including CAPA systems and Document Control Systems.
Proficient knowledge of regulatory requirements (e.g., cGMP, 21CFR4,21CFR 210, CFR211, CFR820, ISO13485, EUMDR)
Demonstrated strong oral and written communication and interpersonal interaction skills.
Demonstrated strong technical writing skills.
Previous regulatory inspection readiness and inspection execution experience.
Attention to detail, self-management, problem solving; mentoring.
Previous experience with CAPA management systems including TrackWise.
Travel may be required for initialmentoring and onboarding, up to and including a Short Term Assignment
The position is for the Lilly Concord site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.
Ability to work 8-hour days – Monday through Friday.
Ability to work overtime as required.
Travel may be required for initial mentoring and onboarding, including potential for aShort Term Assignment
This job description 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 description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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 ( LillyRecruitingCompliance@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.
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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.