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 39,000 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.
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 39,000 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. #WeAreLilly
Lilly is a fortune 500 company in operation for over 140 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.
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 Quality Assurance Manager is responsible for support of the parenteral area staffing, training, and leadership of the quality assurance group supporting the project delivery, process development, operational readiness, start up, and validation of the parenteral area including dispensing, equipment prep, formulation, filling, and inspection of pre-filled syringe. After start up, the manager will continue to help build a strong quality culture and lead the QA team for oversight and support of the ongoing operation as well as site inspection readiness and execution.
Act in the project phase as a cGMP expert, working with Global Facility Delivery, Lilly project staff, and selected A&E firm to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design.
Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.
Consult with Network and Global quality groups including the GQS, ETC, GPP and SAT Hub as required to ensure consistent and compliant approach is executed during the project and startup phase.
Actively participate in required design reviews and final design qualification activities.
Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
Support the Site Quality Leader in the development of the site organization, creation of the Quality Management System implementation plan, and execution of site quality operations in the parenteral area.
Supporting the site to ensure a safe work environment including supporting and leading safety efforts for your team.
Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures for the parenteral area.
Build a diverse and capable site organization to support quality oversight, and ensure compliance with area procedures and controls for:
Automated visual inspection and AQL.
Site batch review and release.
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
Supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment
Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
Network with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
Support site inspection readiness and execution.
Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.
Setting of area human resource and business plan goals.
At least 7 years working in the pharmaceutical industry in QA/QC roles.
Previous management or leadership experience including leading or working effectively with a cross functional group.
Strong knowledge of Quality Management Systems and applicable regulatory requirements.
Previous regulatory inspection readiness and inspection execution experience.
Previous experience directly supporting a parenteral manufacturing operation.
Excellent interpersonal, written and oral communication skills
Strong technical aptitude and ability to train and mentor others
Ability to work 8 hour days – Monday through Friday
Ability to work overtime as required
Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
Previous facility or area start up experience.
Previous equipment qualification and process validation experience.
Previous experience with SAP or other inventory management systems.
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 deviation and change management systems including Trackwise
Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study.
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.
Position may require a short duration assignment of 2-3 months in Indianapolis to establish specific parenteral knowledge and establish global contacts.
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.