- 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
- Edwards Lifesciences (Greensboro, NC)
- …the Cordella PA Sensor is revolutionizing how heart failure is managed, improving quality of life while slashing hospital admissions and health care costs along the ... You! IHFM has achieved a significant milestone and received FDA approval for our Cordella PA Sensor. Join us...revolutionary heart failure management system! As the Area Sales Manager at IHFM, you will play a pioneering role… 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 ... Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data...Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus… more
- Fluor (Raleigh, NC)
- …capital projects for our clients? We are looking for an accomplished Engineering/Design Manager for current projects in the Life Sciences market. In this position, ... and standards * Collaborate with cross-functional teams, Construction, Procurement, Contracts, Quality , Project Controls, HSE, HR, IT and CQV, to align design… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …work in 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 ... organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …research-based pharmaceutical company. POSITION SUMMARY: Under the direction of the Senior Manager , Quality Compliance, the Quality Compliance Specialist is ... Quality Compliance Specialist Department: Quality Location:...of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as they relate to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …to regulated and semi-regulated countries. POSITION SUMMARY: Under the direction of the Director/ Manager , Quality Systems, the Quality Systems Specialist is ... Quality Systems Specialist Department: Quality Plant...of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as they relate to… more
- CaroMont Health (Gastonia, NC)
- Job Summary: Works closely with director, operations manager , and section managers to coordinate activities of the Laboratory Quality Management Plan. Conducts ... Mt. Holly, and CMG Hematology Oncology. Works closely with director, operations manager , and section managers to maintain the laboratory readiness for scheduled and… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and ... donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a lead resource… more