Roles & Responsibilities: Leading supplier qualification activities for new components and processes. Planning, executing, and documenting IQ/OQ/PQ and component/process qualifications. Reviewing supplier documentation such as FAIs, pFM...
Job Description: As a Manufacturing Program Manager, you are responsible for leading large programs that involve multiple manufacturing, testing and storage locations across the globe. The scope of the programs you lead typically include...
Summary: Writing and execution of validation protocols and reports (i.e. IQ, OQ, PQ, etc.) Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness...
Job Description: The Manufacturing Execution System (MES) Quality Engineer II position will work closely with the IT, Operations, Validation, and Engineering, teams to ensure that projects (new MES deployments, sustaining, and/or optimiza...
Roles & Responsibilities: Own end-to-end deviation investigations and effectively collaborate cross-functionally to ensure a thorough, risk-based investigation is conducted for each quality event commensurate with the event classification...
Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, pediatric planning, and accelerated procedures, e...
Roles & Responsibilities: Writing and execution of validation protocols and reports (ie. IQ, OQ, PQ, etc.) Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, pro...
Roles & Responsibilities: Lead cost optimization initiatives across supply chain and procurement functions, ensuring measurable savings. Coordinate cross-functional teams to drive efficiency in sourcing, vendor management, and logistics....
Responsibilities: Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. Provide strategic oversight and direction to CRO clinical data m...
Roles& Responsibilities: Lead the development, execution, and approval of validation master plans, validation plans, IQ/OQ/PQ protocols, and final reports, with emphasis on sterilization, endotoxin control, and microbiology-related proces...