- 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 ... disease ( **PH-ILD** ) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis ( **PF** ). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of ... global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet… more
- Sumitomo Pharma (Raleigh, NC)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- ITW (Washington, NC)
- …to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including ... assignment of primary contacts and coordinating training support. Ensure 100% alignment with Divisional Standards. + Ensure Management Reviews are conducted to provide for systems review. + Manage Internal Audit Program. New/Change Product/Process Validation +… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …guidelines of bioMerieux's Quality System. Adhere to Regulatory requirements, including FDA , ISO, Legal, Ethical, and bioMerieux-specific procedures. + Source a ... variety of materials, equipment, and services in accordance with prescribed purchasing regulations and procedures + Master markets related to assigned categories/commodities, with a focus on soft-services. Seek of opportunities that serves Corporate… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …of 10 years relevant experience - Experience in dealing with the FDA regarding license submissions, inspections and audit follow-up required - Aeseptic/sterile ... filling experience preferred *Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level… more
- J&J Family of Companies (Wilson, NC)
- …initiatives or other projects as needed in the capacity of a project manager or a subject matter expert. Conducts technical and validation studies. This position ... and technical training as required. + Serves as project manager for the change process and provide coordination to...Expert (SME) during internal and external regulatory audits (including FDA , EMEA). + Maintains various databases of production and… more
- US Tech Solutions (Wilson, NC)
- …new users to the system and assign privileges as directed by the QA Systems Manager + Set up review and approval routings for SOPs and other GMP regulated documents ... as directed by the QA Systems Manager + Track documents through the review and approval...within the biological and/or pharmaceutical industry + Knowledgeable of FDA /EMEA regulatory requirements applicable to biologics and/or pharmaceuticals and… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary ... Responsibilities** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma… more