- AUROBINDO (Durham, NC)
- …for study types ranging from reverse engineering to method development/ validation to product characterization.. Drafts protocols and performs experiments ... independently with some guidance from Director . Organizes and presents data to support and document product development decisions. Leads investigations to support… 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 ... collaboration to drive continuous improvement and adherence to regulatory standards. The Director , Process Validation is crucial in enhancing the site's … more
- Fujifilm (Holly Springs, NC)
- …to ensure full CGMP compliance by operations launch * Ensures the integration of process validation (PV), CV, and computerized system validation (CSV) into ... **Position Overview** The Associate Director , Cleaning Validation is responsible for...This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment… more
- IQVIA (Durham, NC)
- …expertise, science, & technology, and be the employer of choice **The Role:** This Senior Director role oversees the RDS IT Validation & Compliance team of 30+ ... RDS IT systems and processes. **Essential Functions:** + Defining & executing validation strategy to improve quality & compliance, ensures adherence to global… more
- Stantec (Raleigh, NC)
- …design intent and client/user and regulatory requirements. Working under the guidance of Director of commissioning/ validation , you will work on a variety of ... reports to assist in closure of protocols. - Assist Director of Commissioning/ Validation with client presentations, client...At Stantec we are committed to ensuring our recruitment process is accessible to all. If you require reasonable… more
- Lilly (Raleigh, NC)
- …provide increased technical capacity across the network. **Position Brand Description:** The Director /Senior Director , Global Process Owner for Sterility ... agency standards, industry trends and scientific principles. **Key Objectives/Deliverables** **The Director /Senior Director , Global Process Owner for… more
- Fujifilm (Holly Springs, NC)
- …associated support functions such as Process Science, Engineering Science, Process Engineering, Validation , and Automation + Ensures the quality assurance ... standards + Approves critical lifecycle documentation, including risk assessments, product/ process /equipment specifications, functional specifications,traceability matrices, qualification protocols, validation… more
- United Therapeutics (Research Triangle Park, NC)
- …Product (SAP), MasterControl, MiniTab, Trackwise, and Empower software systems + Continuous Process Validation experience + Knowledge of software validation ... and process development and improvement, implementation of product/ process verification, validation activities, and commercialization. Responsibilities for… more
- Meta (Raleigh, NC)
- …an experienced New Product Integration Director to drive the end-to-end process of transitioning hardware platforms from validation through to production ... role is responsible for leading the complex, multi-phase New Product Introduction (NPI) process that moves compute, storage, and network hardware from ODM, OEM, and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …environments and regulatory requirements (FDA, EMA, ICH). + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …for technology transfer activities to new or existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global ... robust and compliant manufacturing processes through effective technology transfer, validation , process monitoring, and lifecycle management. This individual… more
- United Therapeutics (Research Triangle Park, NC)
- …our GxP Systems, SAP, and Automation & Control teams. The Associate Director , Operational Technology will provide leadership and management of Operational Technology ... staff and ensure the ongoing development of the team. The Associate Director , Operational Technology will maintain a strategic approach to technology and automation… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- The Director , Strategy & Analysis and Contract Operations is responsible for directing and conducting pricing analysis of government policy and evaluating pricing ... for Gross to Net (GTN) forecasting, government price reporting, and rebate invoice validation and payment operations. This role leads an operations team and oversees… more
- United Therapeutics (Research Triangle Park, NC)
- …to "roll up your sleeves" and be hands-on whenever needed. The Senior Director of Quality Operations for Solid Dose leads site quality operations, including all ... manufacturing, packaging and distribution quality. This person drives lifecycle process quality in Manufacturing, Packaging, Distribution & CMOs, ensuring compliance… more
- Sumitomo Pharma (Raleigh, NC)
- …& Project Management, including the Software Development Lifecycle and Computer Systems Validation process + Excellent communication skills The base salary range ... dynamic, highly motivated, and experienced individual for the position of **Associate Director , Clinical Systems R&D IT Business Applications** who will serve as the… more
- Amgen (Holly Springs, NC)
- …us and transform the lives of patients while transforming your career. **Associate Director Information Systems** **What you will do** Let's do this. Let's change ... and Business Practice. The Capital portfolio spans across multiple functions; Process Development, Manufacturing Clinical & Supply Chain, and Commercial areas and… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... product at CDMOs + Design and lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and… more
- Ford Motor Company (Raleigh, NC)
- …way the world moves? **In this position ** We are seeking an Executive Director of Functional Safety to lead the development and implementation of functional safety ... regulatory and internal standards. + Establish and refine safety assessment and validation methodologies to improve early detection and mitigation of safety risks. +… more
- Eaton Corporation (Raleigh, NC)
- **Primary Function:** Eaton Corporation is seeking an Engineering Director , Digital Solutions, to lead a high-performing team dedicated to delivering simplified, ... strong project management processes around requirements gathering, software development & validation (scrum teams), testing and production support. + Manage the… more
- Sumitomo Pharma (Raleigh, NC)
- …undefined + undefined + Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments. + Work closely with ... follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the… more
