- Honeywell (Charlotte, NC)
- …execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, digital transformation ... in addressing critical challenges including technology transfer, batch execution, quality management, regulatory compliance , and operational efficiency. **Key… more
- Teleflex (Morrisville, NC)
- …as required by facility requirements. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the ... Clinical Affairs Manager (REMOTE) **Date:** Aug 11, 2025 **Location:** Morrisville,...driven by our purpose to improve the health and quality of people's lives. Through our vision to become… more
- Novant Health (Charlotte, NC)
- Job Summary The Cell Processing Lab Manager is an integral leader within our growing cross-market Transplantation and Cellular Therapy Program. + Oversees all ... lymphocytes, and other cellular therapy products such as CAR-T. Monitors quality assurance activities and compliancewith regulatory entities including FACT, CLIA,… more
- BioLife Plasma Services (Raleigh, NC)
- …application is true to the best of my knowledge. **Job Description** ** Manager Trainee- Operations (Travel Program- Relocation Required)** Position is based in a ... BioLife, opportunities to build a fast-paced career are within your reach. As a ** Manager Trainee** , you will participate in a training program that will further… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …the direct supervision of the Quality Systems Manager , perform quality assurance and Training functions to ensure compliance with internal and external ... the Quality Systems Manager , perform quality assurance and Training functions to ensure compliance... FDA regulations. Strong integrity and commitment to quality and compliance . Good knowledge of mathematics.… more
- Sumitomo Pharma (Raleigh, NC)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Manager of Biostatistics to serve as trial statistician for one or more clinical ... Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional… more
- ThermoFisher Scientific (Greenville, NC)
- …which includes a drug screening. **POSITION SUMMARY** The Sterility Assurance Manager is accountable for sterility assurance across site and will own/promote/define ... (ie new lines/processes) + Implementing standard methodology (ie ensuring understanding / compliance with updated Annex 1 - leading the transition and any risk… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... currently an option. **Who You Are** The Strategic Development Clinical Operations Manager is responsible for the execution of study-level activities including but… more
- BioFire Diagnostics, LLC. (Durham, NC)
- … compliance with company policy and within the guidelines of bioMerieux's Quality System. Adhere to Regulatory requirements, including FDA , ISO, Legal, ... assigned categories to leverage opportunities and innovation. Assist in the Quality Management System (QMS) audits/site supplier visits to ensure the relationship… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes **Additional ... responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA … more