- Fujifilm (Holly Springs, NC)
- **Position Overview** The Associate Director , Cleaning Validation is responsible for leading and executing Cleaning Validation (CV) activities for a large-scale ... mitigate risks associated with the therapeutic product lifecycle. The Associate Director collaborates with cross-functional teams to drive continuous improvement and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- The Senior Director , Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned ... journals + Direct agency and vendor relationships to deliver high quality publication deliverables **Congress Planning** + Set strategic priorities for congress… more
- Endo International (Raleigh, NC)
- …our vision of helping everyone we serve live their best life. **Job Description Summary** The Quality Control (QC) Manager serves as a Quality Control ... all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and… more
- Lilly (Concord, NC)
- …now is the perfect opportunity! During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and leadership of the ... by example and provide coaching to others in the areas of safety, quality , operational excellence, compliance, and continuous improvement. The AD will be responsible… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Director , Process Validation plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing Science ... to drive continuous improvement and adherence to regulatory standards. The Director , Process Validation is crucial in enhancing the site's process validation… more
- Fujifilm (Research Triangle Park, NC)
- …Lead the engineering engine that powers cutting-edge biomanufacturing. As Senior Director , Engineering & Facilities, you will own the strategy, execution, and ... engineering, utilities, CQV, security, and capital projects-ensuring world-class reliability, quality , safety, and compliance. **Company Overview** At FUJIFILM Biotechnologies,… more
- Catalent Pharma Solutions (Greenville, NC)
- ** Director , Supply Chain** **Position Summary:** + 100% on-site Our Greenville, NC site specializes in end-to-end turn-key solutions for oral solid dosage forms, ... formulation development, analytical services, commercial manufacturing, and packaging. The Director , Supply Chain role provides strategic leadership across all… more
- ThermoFisher Scientific (Greenville, NC)
- …of decisions and minutes. + Manage global labeling compliance activities, including quality control , FDA-508 compliance, and annual reporting requirements (US ... approvals. + **Regulatory & Cross-Functional Support** + Prepare change control documentation and deviation reports for foundational and non-foundational markets.… more
- GRAIL (Durham, NC)
- …United Kingdom. It is supported by leading global investors and pharmaceutical , technology, and healthcare companies. For more information, please visit grail.com ... and other relevant documentation. The role collaborates cross-functionally with Quality , Lab Operations, and other stakeholders to support regulatory strategy… more
- Merck (Raleigh, NC)
- …workflows. **Required Skills and Experience:** + Knowledge of manufacturing, testing, quality , and supply chain processes from late clinical development through ... regulatory content + Understanding of CMC operations, technology transfer, control strategy development, and regulatory authoring requirements that inform automated… more