Current jobs related to Sr. Principal - Durham, North Carolina - Eli Lilly and Company

  • Senior Principal Architect: PCIe Endpoint

    2 weeks ago

    Durham, North Carolina, United States Ampere Computing Full time

    About the RoleWe are seeking an experienced Senior Principal Architect to lead the development of our PCIe endpoint architecture. This is a critical role that will involve defining the hardware implementations and software communication algorithms of our product.Key ResponsibilitiesOwn the architecture of the product from initial path-finding to production,...

  • Sr. Principal Engineer – Parenteral Engineering

    2 months ago

    Durham, United States Eli Lilly and Company Full time

    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...

  • Sr. Principal Engineer – Parenteral Engineering

    2 months ago

    Durham, United States Eli Lilly and Company Full time

    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...

  • Sr. Principal Architect: PCIe Endpoint

    2 weeks ago

    Durham, United States Ampere Computing Full time

    Description Invent the future with us. Recognized by Fast Company's 2023 100 Best Workplaces for Innovators List, Ampere is a semiconductor design company for a new era, leading the future of computing with an innovative approach to CPU design focused on high-performance, energy efficient, sustainable cloud computing. By providing a new level of...

  • Clinical Research Nurse Coordinator Sr

    1 month ago

    Durham, United States Duke University Full time

    School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great...

  • Clinical Research Nurse Coordinator Sr

    24 hours ago

    Durham, United States Duke University Full time

    School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas...

Sr. Principal

4 months ago

Durham, North Carolina, United States Eli Lilly and Company Full time

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.

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.

Position Description:

Senior Principal Associate – QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP.

Key Objectives/Deliverables:

Coordinates and manages regulatory inspections including logistics and data system(s).Implement and Lead the site inspection readiness programImplement and Lead the Quality Oversight programActs as data steward and trainer for site audit data system(s)Leads inspection readiness huddlesMonitor and report on the status and effectiveness of the inspection readiness program and needed improvementsPerform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program.Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organizationLeads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementationServe as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the siteLead and model behaviors foundational to strong quality culturePerforms site self-inspections, as necessarySupport site safety initiatives.Basic Requirements:BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree10+ years of experience in pharmaceutical and/or medical device industryPreferred attributes but not required:Extensive knowledge of external Regulations and Lilly Quality System requirementsAbility to function in a team environment as a leader and as a team memberDemonstrated ability to partner/network with other sitesDemonstrated participations in inspections and inspection readiness activities including acting as an audit host.Demonstrated ability to manage projects.Proficiency with computer systems.Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activitiesGood knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiencyStrong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment.Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site GoalsAdditional Information:US/OUS travel may be requiredFlex hours possibleSite operates 24/7 - overtime may be required 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 ( ) 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. #WeAreLilly