Sr. Manager

3 weeks 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:

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging 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 Sr Manager for QA Visual Inspections Operations is responsible for providing leadership and daily support and oversight to STAT/SORT operations at Research Triangle Park Parenteral Manufacturing facility. The Sr Manager assists the Associate Director-QA Parenteral in managing daily work of personnel and tracking department metrics to ensure productivity and alignment with departmental and site goals. The QA Sr. Manager ensures QA oversight of the AQL and batch sampling process to meet business requirements. The QA VI Sr. Manager is also responsible for individual contributor activities that may include SME and Process Owner within area of responsibility as well as process improvements.

Responsibilities:

Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.Responsible for managing 4 - 8 QA VI Technicians supporting the AQL sampling, inspection and sample submission for the semi-finished syringe visual inspection process. Ensures adequate staffing and coverage within area of responsibility.May be required to support inspection based tasks.Participate in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports, recruit new talent and grow team capabilities.Mentor, coach and provide feedback to employees for performance and development.Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.Lead, mentor, and coach Quality VI technicians, Operations, and support personnel on quality matters, such as AQL and sampling, while driving the site Quality culture.Responsible for ensuring team is trained and training remains in compliance.Ability to assess, create, and triage deviations / observations that occur within the parenteral areas.Reviews and approves GMP documentation in support of daily operations such as: Maintenance Action Plans, Return to Service and Release of equipment, product, and area holds, spare parts consultation, work order assessments and issue resolution, and other documentation as required.Troubleshoot and provide QA systems support to reconcile issues in multiple systems (i.e., SAP, PMX. TrackWise, SmartLab, GMARS, and other systems as required.)Participate in self-led inspections and provide support during internal / external regulatory inspections.Review and / or redline to GMP documents ensure quality attributes are met. (i.e., deviations / observations, procedures, production records, etc.).Communicates with Associate Director and Quality Representatives on quality and operational issues.Work cross functionally and collaboratively with all levels of the organization. Basic Requirements: Bachelor's degree or equivalent experience5 years experience in quality role supporting parenteral manufacturing operations.Experienced in performing AQL post visual inspection via manual, semi-automated and automated inspection processes.
Additional Skills/Preferences:Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.Demonstrated strong oral and written communication and interpersonal skills.Demonstrated decision making and problem-solving skills.Demonstrated knowledge and understanding of manufacturing process and Quality Systems.Proficiency with inventory management systems and deviations systems, (i.e. SAP, Trackwise, etc.)Strong attention to detailProven ability to work independently or as part of a team to resolve issues.
Additional Information:Position is first shift Monday - Friday. Pass visual exam for 20/20 vision with or without correction and must pass colorblindness exam.May be required to respond to operational issues outside of core business hours / days.Ability to work overtime, as requested.Applicant may work in various areas within Parenteral Building. Mobility requirements should be considered when applying for this 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 ( ) 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

  • Sr Director, Manufacturing Controlling, Americas

    2 weeks ago

    Durham, North Carolina, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description Position Summary:Reporting to the Sr. VP Global Manufacturing, Supply Chain, and Quality and functionally to the Sr VP Manufacturing Americas, you are the finance business partner of manufacturing across the plants in the Americas, with the exception of our plant in Salt Lake City. You manage a team of local controllers who support the...

  • Sr. Integration Tester

    4 weeks ago

    Durham, North Carolina, United States Cognizant Technology Solutions Full time

    Sr Product Assurance ManagerQualification:Engineering with specific specializationResponsibility:Product Assurance Plan: 'PAP Generation. 1) Generate a PAP for all life cycle processes The PAP may require. updating throughout the life cycle Outputs of other activities are. inputs to the PAP. 2) Establish a baseline PAP prior to the Requirements V&V...

  • Lead Maintenance Tech

    3 days 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...

  • IT Sr Technical Specialist/AWS Cloud Engineer

    2 weeks ago

    Durham, North Carolina, United States Labcorp Full time

    Labcorp, a premier global player in life sciences, leads the charge in patient care through advanced clinical laboratory services, diagnostics, drug development, and technology-driven solutions. We are dedicated to innovation and excellence, actively seeking skilled professionals to contribute to our global mission of enhancing health and transforming...

  • Sr. Manager, Commercial Analytics

    1 week ago

    Durham, United States Biofire Diagnostics, LLC Full time

    The Sr. Manager of Commercial Analytics is responsible for assisting in developing and executing the advanced analytics strategy, frameworks, and methodologies for the U.S. Commercial Operations teams. Ensuring the Commercial Analytics team provides Analytics, Commercial, Manager, Data Architect, Support, Business, Manufacturing, Business Services

  • Sr Manager, Events

    2 weeks ago

    Durham, United States Biofire Diagnostics, LLC Full time

    BioMerieux, a global leader in medical diagnostics, is seeking a seasoned Sr. Manager to lead our dynamic Trade Shows & Events team. You will play a pivotal role in crafting exceptional brand experiences that drive awareness, engagement, and lead gen Trade, Manager, Customer Experience, Project Management, Event, Leadership, Manufacturing, Business Services

  • Sr. Manager

    3 weeks 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. Manager

    3 weeks ago

    Durham, United States Eli Lilly 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 Onsite Discharge Planner

    6 days ago

    Durham, United States Blue Cross Blue Shield of North Carolina Full time

    The Sr Onsite Discharge Planner is a hybrid role involving remote and onsite work in one or more NC behavioral health facilities to coordinate the care and services of inpatient members from time of admission to discharge. The Sr Onsite Discharge Pla Behavioral Health, Behavioral, Planner, Health, Behavior, Management, Insurance, Healthcare

  • Sr. Manager, Commercial Analytics

    1 week ago

    Durham, United States Biomerieux S.A. Full time

    Description Position Summary The Sr. Manager of Commercial Analytics is responsible for assisting in developing and executing the advanced analytics strategy, frameworks, and methodologies for the U.S. Commercial Operations teams. Ensuring the Commercial Analytics team provides strategic business insights and actionable recommendations in support of the...

  • Sr. Manager, Commercial Analytics

    1 week ago

    Durham, United States Biofire Diagnostics Full time

    Position Summary The Sr. Manager of Commercial Analytics is responsible for assisting in developing and executing the advanced analytics strategy, frameworks, and methodologies for the U.S. Commercial Operations teams. Ensuring the Commercial Analytics team provides strategic business insights and actionable recommendations in support of the product...

  • Sr. Manager, Commercial Analytics

    1 week ago

    Durham, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description Position SummaryThe Sr. Manager of Commercial Analytics is responsible for assisting in developing and executing the advanced analytics strategy, frameworks, and methodologies for the U.S. Commercial Operations teams. Ensuring the Commercial Analytics team provides strategic business insights and actionable recommendations in support of the...

  • Sr. Engineer III, Automation

    2 weeks ago

    Durham, United States Biogen Full time

    Reporting to the Head of RTP Site Automation, the Sr. Engineer III is a Subject Matter Expert (SME) in Distributed Control Systems (Delta. V DCS), Building management Systems (Rockwell BMS), Automation for Manufacturing Execution Systems (Syncade MES Automation, Engineer, Reliability Engineer, Business Development, Operations, Industry

  • Sr. Lab Systems Support Administrator

    12 hours ago

    Durham, United States Tekniforce Full time

    We are looking for an Sr. Lab Systems Support Administrator. This is an on-site 6 (six) months contract to possible hire position in Durham/RTP North Carolina with our client. In this role as a Sr. Lab Systems Support Administrator, you will be responsible for troubleshooting and problem resolution, management of system resources, internal user performance,...

  • Sr. Solution Engineer

    4 weeks ago

    Durham, United States HonorVet Technologies Full time

    Title: Sr. Solution Engineer Duration: 6+ months Location: Durham, NC Client requires a Senior Software engineer to provide software solution to business requirement using low code on cloud platforms. The Department seeks a contractor resource as a Senior Software Engineer responsible for working with the Architects and developers to provide software...

  • Sr. Solution Engineer

    6 hours ago

    Durham, United States HonorVet Technologies Full time

    Title: Sr. Solution Engineer Duration: 6+ months Location: Durham, NC Client requires a Senior Software engineer to provide software solution to business requirement using low code on cloud platforms. The Department seeks a contractor resource as a Senior Software Engineer responsible for working with the Architects and developers to provide software...

  • Sr Mechanical Engineer 2

    2 weeks ago

    Durham, United States Sunrise Systems Full time

    Our client, a leading Medical Devices Manufacturing Company is looking for Sr Mechanical Engineer and This is for an initial duration of Months at Durham, NC   Job Title: Sr Mechanical Engineer Job Id: - Location: Durham, NC Duration: Months Contract Position Type: Hourly Contract Position (W only) Onsite daily Description: As a...

  • Sr. Java Developer

    22 hours ago

    Durham, United States Compunnel Inc. Full time

    Role - Sr. Java Developer Location - Durham North Carolina Hybrid - 5 days onsite a month Must Have - Java 11 or higher (some key areas like Multithreading, Concurrency, REST API Development) with Spring Boot Framework, NodeJS, CI/CD, and JUnit and 1-3 years AWS (Dynamodb, Lambda, S3, ECS, Elasticache, CFN, SQS) – SDK for coding, developer certificate Have...

  • Sr. Java Developer

    1 day ago

    Durham, United States Compunnel Inc. Full time

    Role - Sr. Java Developer Location - Durham North Carolina Hybrid - 5 days onsite a month Must Have - Java 11 or higher (some key areas like Multithreading, Concurrency, REST API Development) with Spring Boot Framework, NodeJS, CI/CD, and JUnit and 1-3 years AWS (Dynamodb, Lambda, S3, ECS, Elasticache, CFN, SQS) – SDK for coding, developer certificate Have...

  • Sr. Java Developer

    13 hours ago

    Durham, United States Compunnel Inc. Full time

    Role - Sr. Java Developer Location - Durham North Carolina Hybrid - 5 days onsite a month Must Have - Java 11 or higher (some key areas like Multithreading, Concurrency, REST API Development) with Spring Boot Framework, NodeJS, CI/CD, and JUnit and 1-3 years AWS (Dynamodb, Lambda, S3, ECS, Elasticache, CFN, SQS) – SDK for coding, developer certificate Have...

  • Sr. Java Developer

    8 hours ago

    Durham, United States Compunnel Inc. Full time

    Role - Sr. Java Developer Location - Westlake TexasHybrid - 5 days onsite a month Must Have - Java 11 or higher (some key areas like Multithreading, Concurrency, REST API Development) with Spring Boot Framework, NodeJS, CI/CD, and JUnit and 1-3 years AWS (Dynamodb, Lambda, S3, ECS, Elasticache, CFN, SQS) – SDK for coding, developer certificate Have strong...

  • Sr. Java Developer

    3 hours ago

    Durham, United States Compunnel Inc. Full time

    Role - Sr. Java Developer Location - Westlake TexasHybrid - 5 days onsite a month Must Have - Java 11 or higher (some key areas like Multithreading, Concurrency, REST API Development) with Spring Boot Framework, NodeJS, CI/CD, and JUnit and 1-3 years AWS (Dynamodb, Lambda, S3, ECS, Elasticache, CFN, SQS) – SDK for coding, developer certificate Have strong...

  • Sr. Administrative Assistant

    5 hours ago

    Durham, United States Amiseq Inc. Full time

    Sr. Administrative Assistant - SalesDurham, NC - Hybrid role12 Months ContractSearching for a talented Sr. Administrative Assistant to help provide administrative to Vice Presidents and levels of professionals within the Sales organization. Client seeks the best and brightest candidate who values professional relationships complimented by creativity and team...

  • Sr. Information Security Analyst

    7 days ago

    Durham, United States Latino Credit Union Full time

    Job Type Full-time Description The Sr. Information Security Analyst will safeguard LCCU's enterprise networks, systems, and applications against cyber threats. Will play a critical role in ensuring the security and integrity of LCCU's digital assets, ensuring the trust and confidentiality of LCCU's sensitive data and assets. Sr. Information Security Analyst...