- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Salary Range: Dependent on Qualifications/Experience Position Summary/Description: The purpose of the Regulatory Associate Lead is to facilitate the conduct ... regulatory meetings, and signing off on timecards for Regulatory staff * Taking a lead role in activation of new oncology clinical trials, including… more
- United Therapeutics (Research Triangle Park, NC)
- …preclinical studies to ensure the successful submission and approval of a drug product by regulatory agencies. This is a hybrid position with 4 days a week onsite in ... Development Manager and/or Program Head to coordinate, manage, and lead the overall execution of clinical studies or group...and results; Work with other internal functional areas (eg, Regulatory , Safety, Data Management) to support the study +… more
- Lilly (Durham, NC)
- …who are determined to make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging is responsible for the staffing, training, ... and Packaging (DAP) production area at Lilly RTP. The Associate Director will help build a strong quality culture...Director will help build a strong quality culture and lead the QA team for oversight and support of… more
- Teleflex (Morrisville, NC)
- Associate Global Medical Safety Director (Part Time/Remote US) **Date:** Dec 26, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : ... issues, development, and execution of strategy for the CMA function, and co- lead cross-functional complex projects. The role provides an expert medical resource to… more
- Lilly (Durham, NC)
- …who are determined to make life better for people around the world. Associate Director Quality Assurance (QA) Parenteral is responsible for the staffing, training, ... dispensing, equipment preparation, formulation, filling and visual inspection. The Associate Director will help build a strong quality culture...Director will help build a strong quality culture and lead the QA team for oversight and support of… more
- Banfield Pet Hospital (Wake Forest, NC)
- JOB TITLE Shift Lead TEAM Hospital FUNCTION, FAMILY Service Operations (Pet), Hospital Operations (Pet) COST CTR # Varies REPORTS TO Practice Manager JOB LEVEL B4 ... FUNCTION The primary purpose and function of the Shift Lead is to perform the duties of a CSC...team to ensure quality medical care, exceptional client service, associate engagement and maximum productivity. Provide professional, efficient and… more
- Merck (Durham, NC)
- **Job Description** ** Associate Director - Mechanical Utility Engineer - P4/Band 400** The candidate will be a member of the Technology Center Mechanical Utility ... Primary activities will include, but are not limited t** o: + Lead or support project Mechanical Utility design efforts, providing compliant, innovative solutions… more
- Lilly (Durham, NC)
- …- $46.88 The Lead Technician - Manufacturing PMX will report to an Associate Director of Packaging Operations. The Lead Technician - Manufacturing PMX will ... groups to support event management, change controls, etc. The Lead Technician - Manufacturing PMX will also assist the...all HSE Goals + Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and… more
- Lilly (Durham, NC)
- …to end user functionality and to system compliance with company and regulatory requirements. Responsibilities will involve interacting with global and local IT ... the validated state of software-based computerized systems in use in the laboratory. + Lead site deployment and upgrades of QC laboratory IT systems such as Empower,… more
- IQVIA (Durham, NC)
- …statistical oversight for clinical trials, including: + Support and mentor lead statistician. + Perform senior level review of biostatics deliverables, including ... mentoring, training, and statistical support for Biostatistics staff. + Serve as lead statistician for one or more clinical trials, including: client interface,… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …as hydrology, environmental justice, and data science. This position will 1) lead operationalizing existing remote sensing of water quality workflows and integrating ... of how remotely sense water quality data can be combined with key regulatory , river access, and socioeconomic data to improve decision making and identify… more
- Merck (Durham, NC)
- …capability at the Durham site. The successful candidate will report to the Associate Director, Laboratory Operations to lead start-up new laboratories for ... concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgeting + Build… more
- Banfield Pet Hospital (Morrisville, NC)
- …FUNCTIONThe primary purpose and function of the Area Chief of Staff is to lead , develop and manage associate veterinarians in their hospitals to ensure Banfield ... and quality audits to ensure hospital compliance with industry, regulatory and Banfield quality standards while building associate... and locum veterinarians in their hospitals. + Develop associate and lead veterinarians to coach new… more
- Merck (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract ... site business processes, such as change control, deviation management, audits and regulatory inspections. The Manager will be responsible for using principles of our… more
- Interstate Blood Bank (Research Triangle Park, NC)
- …with a specialized focus on human biological raw materials, cell sourcing, and regulatory compliance in cell therapy processes. This role requires a strategic leader ... **Responsibilities include but are not limited to:** _Business Development Strategy_ 1. Lead the development of a business strategy for cell therapy, emphasizing… more
- Lilly (Durham, NC)
- …better for people around the world. **Organization Overview:** The QA Sterility Assurance associate is a member of the Quality Assurance team and teaches, mentors, ... ensuring they are aligned with all appropriate quality standards and current regulatory and industry expectations. This individual will participate in regulatory … more
- Lilly (Durham, NC)
- …the business + Lead area tours to support business reviews and / or regulatory audits + Trained as a Lead Investigator + Development and monitoring of ... facility and Quality System from the ground up. **Responsibilities:** The Operations Associate (OA) will report to the Director of Operations (Formulation and… more
- Sysco (Morrisville, NC)
- …with all Insurance Pooling requirements; with local, state, federal and provincial regulatory agencies (ie OSHA, DOT, FDA, USDA, DOL, CVOR (Canada), etc.); with ... necessary, participate in grievance or arbitration proceedings. + Maintains associate relations through regular department meetings; maintains on-going interaction;… more
- Lilly (Durham, NC)
- …Objectives/Deliverables:** + Enforce compliance to all procedures, methods, and other regulatory commitments as relating to EM, as well as applicable production ... Minimum 4 years of experience in Environmental Monitoring + Associate degree OR High School Diploma/GED with 4+ years...Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable. + Understanding of regulatory … more
- Lilly (Durham, NC)
- …to make life better for people around the world. The Quality Assurance Associate for Materials Management is responsible for the site parenteral & device materials ... management systems. The Materials Management associate provides Quality Oversight for the suppliers and materials utilized by the site. This position supports all… more