- Fujifilm (Holly Springs, NC)
- **Position Overview** **Director, QA Drug Substance Operations** Are you a strategic leader with expertise in managing teams of QA professionals and collaborating ... to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and… more
- Pfizer (Groton, CT)
- …operations activities related to the manufacture and disposition of GMP clinical Drug Product. As an Associate Operations Quality colleague, the successful candidate ... will have quality touchpoints prior to the start of drug product manufacturing through disposition of final drug products for clinical use. Paramount to this… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and verbal). Has basic knowledge/understanding of domestic (ie Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. ... and verbal). Has basic knowledge/understanding of domestic (ie Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and verbal). Has basic knowledge/understanding of domestic (ie Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. ... (written and verbal). Demonstrated use of domestic (ie Food and Drug Administrations) and applicable foreign regulatory agency requirements/guidelines. Prior… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical ... applicable internal legal and compliance policies as well as external US-specific regulatory guidelines. + Partners with US Medical TA leadership to determine… more
- Takeda Pharmaceuticals (Boston, MA)
- …high quality analyses of safety information, in support of safety update regulatory submissions, investigational and new drug applications and interactions with ... of 3 years of experience in people management. + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general… more
- Sanofi Group (Morristown, NJ)
- …project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, ... clinical sections of integrated development plans, and submission dossiers for regulatory approval. + Support drug registrations (contribution to submission… more
- Mount Sinai Health System (New York, NY)
- …and maintains overall responsibility for pharmacy operations in the Investigational Drug Service to enhance the reputation and service-orientation of the IDS ... Manager also collaborates and provides expertise in support of clinical investigational drug trials. The Clinical Pharmacy Manager will work collaboratively with the… more
- BeOne Medicines (Pennington, NJ)
- …role in the Manufacturing Science and Technology (MST) department supports BeOne's Drug Product Manufacturing Technology Transfer and support. based in New Jersey ... (Hopewell), this role will be to lead the Hopewell drug product MST function to support technology transfer, validation, continued process verification,… more
- Genentech (Hillsboro, OR)
- **The Position** Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's ... all cGMP operations, ensuring products meet quality standards and regulatory requirements. Quality Assurance responsibilities include ensuring procedures and… more