- GRAIL (Durham, NC)
- …and other stakeholders to support regulatory strategy development, product validation , audits, promotional material review, on-market product support, and change ... disabilities so that they can participate in the job application or interview process , to perform essential job functions, and to receive other benefits and… more
- GRAIL (Durham, NC)
- …For more information, please visit grail.com . Reporting to the Senior Director , Quality Strategy & Operational Excellence, the Senior Quality Specialist is ... and coordinate the CAPA program, NCR program, quality metrics, and quality planning process . + Maintain and improve these programs in compliance with GRAIL's Quality… more
- Winland Foods (Raleigh, NC)
- …shaping the future of manufacturing excellence, we'd love to meet you. The Director of Engineering will lead the development and execution of Winland Foods' ... manufacturing engineering strategy, driving capital investment and process optimization across our network of manufacturing facilities. This leader will guide a team… more
- Endo International (Raleigh, NC)
- …is the primary point of contact for the testing of all raw materials, in- process , finished goods, and stability samples. She/he manages the Quality Control group and ... with GMP and regulatory guidelines.** + **Oversee analysis of raw materials, in- process samples, and finished products to ensure they meet specifications.** +… more
- Ally (Raleigh, NC)
- …scoring models for internal utilization, as appropriate. * Support the Model Risk Management validation process for models owned by your team. **The Skills You ... shouldn't your opportunities be, too? **The Opportunity** Reporting to the Director of Quantitative Modeling, this position's primary responsibilities will include… 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
- Sumitomo Pharma (Raleigh, NC)
- … of the following activities - equipment and utilities qualification/ validation , process development, process validation , continued process ... a dynamic, highly motivated, and experienced individual for the position of ** Director , Commercial Manufacturing Validation ** . This role functions within SMPA's… 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
- 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
- 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
- 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
- Datavant (Raleigh, NC)
- …our bold vision for healthcare. Datavant is seeking a strategic and hands-on ** Director of Quality** to lead product and supplier quality assurance efforts within ... data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of… more
- Insight Global (Durham, NC)
- …timely QA oversight of equipment, computer systems, utilities, facilities, cleaning and process validation . Review and approve GMP documentation developed to ... individual will lead and direct all QA activities supporting Facility Engineering, Validation and IT in a contract manufacturing organization (CMO) setting. Direct… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- **Job Description** The Senior Director , Strategy & Analysis; Contract Operations works cross-functionally to develop and execute pricing strategies for pipeline and ... Leads an operations team and third-party vendor in executing rebate invoice validation and payment, Gross to Net (GTN) forecasting, and government price reporting.… more
- Oracle (Raleigh, NC)
- …and people around the world. Role Overview: OCI Networking is seeking a Senior Director of Physical Networking to lead a global team of network engineers and ... designing and deploying OCI network infrastructure. 3. Oversee the network build process across all OCI data centers and cloud operations, ensuring standardization… 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
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Director , Automation is responsible for setting the direction and managing a central workstream in a $2 billion global project. This ... streamline processes, and leverage technology for improved performance. As the Director , this role bridges the gap between technical expertise and business… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- Director , Training Management Operations Lead The Director , Training Management Operations Lead, is a senior leader within the Learning Center of Excellence ... corporate quality objectives. The position drives governance, technology enablement, and process optimization for training systems and programs across GxP and… more
- Oracle (Raleigh, NC)
- …Description** Oracle Cloud Infrastructure (OCI) is seeking an accomplished Senior Director of Data Center Engineering to lead advanced engineering initiatives that ... data center portfolio. Why Join OCI? As the Senior Director of Data Center Engineering, you will play a...center design and operations through advanced analysis, modeling, and validation . + Oversee CFD modeling of airflow and thermal… more
