- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices. Personnel in this position will: + Follow ... 0 - 2 Years experience in CGMP Operations Background Knowledge & Skills: FDA /CGMP/ Mechanical Aptitude START YOUR APPLICATION… more
- Merck (Wilson, NC)
- …including site inspections, preparation of technical documents for NDA supplements, FDA observation, and environmental process issues. + Responsible for the accuracy ... including site inspections and preparation of technical documents for FDA observation. **Education / Skill Requirements** **Education Minimum Requirement:** +… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …& Risk Management** + Ensure all training programs meet global regulatory standards ( FDA , EMA, ICH, etc.) and internal SOPs. + Monitor training compliance metrics ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs… 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 ... systems are carefully managed to support daily plant operations in a FDA regulated environment supporting DPI manufacturing operations. All life safety systems must… 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 ... Project Management Professional (PMP)-PMI + Experience working in an FDA regulated pharmaceutical manufacturing environment + Experience working on construction… more
- Merck (Durham, NC)
- …degree in science or related field + Bioworks Certificate (working in an FDA or similar regulated industry) + Applicable mechanical and project management experience ... CNC Operations, Computer Literacy, Data Analysis, Driving Continuous Improvement, FDA Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory… more
- System One (Concord, NC)
- …This position ensures trials are executed in accordance with ICH-GCP, FDA , and institutional standards, maintaining participant safety and scientific integrity. The ... or related clinical research. + Comprehensive knowledge of ICH-GCP and FDA regulations. + Strong leadership, communication, and clinical judgment skills. Ref:… more
- Cytel (Raleigh, NC)
- …+ Maintain strong engagement with senior client leadership, regulatory agencies ( FDA /EMA), and key opinion leaders to support and refine development strategies. ... driving high-impact consulting engagements. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to shape and enhance development… more
- Fujifilm (Holly Springs, NC)
- …in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. + Experience in Commissioning, Qualification, and Validation ... operations and/or Quality oversight, in a Food and Drug Administration ( FDA ) regulated facility. **Preferred Requirements:** + Experience and working knowledge of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …the pharmaceutical, biotech, or CRO industry. + In-depth knowledge of ICH-GCP, FDA , EMA, and other global regulatory requirements related to clinical research. + ... + Experience working with CROs or external vendors. + Exposure to FDA or other health authority inspections. **Competencies** **Accountability for Results -** Stay… more