• Director , Global Quality

    Otsuka America Pharmaceutical Inc. (Raleigh, NC)
    The Director , Global Product Quality , GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing ... continuous improvement** across all regions and product lines. The Director will lead global initiatives to harmonize...operational efficiency. + GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg,… more
    Otsuka America Pharmaceutical Inc. (12/16/25)
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  • Associate Director , Global Product…

    Otsuka America Pharmaceutical Inc. (Raleigh, NC)
    **Job Summary** The Associate Director , Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial ... product integrity while optimizing operational efficiency. + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC… more
    Otsuka America Pharmaceutical Inc. (12/02/25)
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  • Associate Director , Global Product…

    Otsuka America Pharmaceutical Inc. (Raleigh, NC)
    **Job Summary** The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight ... and final finished product) for controlled substances + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to… more
    Otsuka America Pharmaceutical Inc. (12/19/25)
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  • Associate Director , Global Supplier…

    Otsuka America Pharmaceutical Inc. (Raleigh, NC)
    The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's ... + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare..., with 2+ years in supplier or external manufacturing quality . + Strong knowledge of GMP regulations… more
    Otsuka America Pharmaceutical Inc. (12/16/25)
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  • Director , QA Drug Substance Operations

    Fujifilm (Holly Springs, NC)
    …across the network + Actively participates in cross-functional initiatives to align global quality strategies + Partners with internal stakeholders and clients ... for you to lead and grow in a world-class Quality organization as the Director , QA Drug...principles **Preferred Requirements:** * 10+ years' experience in a GMP quality assurance (QA) role in commercial… more
    Fujifilm (12/16/25)
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  • Director , Center Quality Ops

    Grifols Shared Services North America, Inc (Research Triangle Park, NC)
    …solutions and services in more than 110 countries and regions. **Summary** : The Director of Quality Operations ensures that all plasma donor centers in the ... Operational Controls** + Ensure plasma collection, processing, labeling, storage, and shipment meet GMP and IQPP standards. + Monitor product quality trends +… more
    Grifols Shared Services North America, Inc (12/13/25)
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  • Senior Director , Quality Operations…

    United Therapeutics (Research Triangle Park, NC)
    …continuous improvement efforts and support initiatives that improve United Therapeutics global quality + Charged with overall responsibility for planning, ... still willing to "roll up your sleeves" and be hands-on whenever needed. The Senior Director of Quality Operations for Solid Dose leads site quality more
    United Therapeutics (10/09/25)
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  • Director , Commercial Manufacturing…

    Sumitomo Pharma (Raleigh, NC)
    Director , Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...are implemented and updated for all development and commercial GMP programs. The individual must have the ability to… more
    Sumitomo Pharma (12/12/25)
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  • Director , Process Validation

    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 (12/16/25)
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  • Manager, Quality Audits

    Grifols Shared Services North America, Inc (Clayton, NC)
    … Management System is required. * Other additional duties may be assigned by the Director Quality Audits from time to time if required. * Ability to travel ... is part of the global GWWO Auditing Department & entails performing routine GMP audits as well as speciality and technical audits in relation to current products… more
    Grifols Shared Services North America, Inc (12/17/25)
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  • Sr. IT Engineer I (OSS Platform)

    Fujifilm (Holly Springs, NC)
    …site in Holly Springs, NC, online. This role functions as a local extension of the Global IT team reporting into the Sr. Director - IT. This role ensures local ... support manufacturing operations from an IT/OT perspective in a global organization. This position acts as a single point...to resolve problems. + Participates in project execution and quality assurance as needed. + Ensures and drives service… more
    Fujifilm (12/16/25)
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  • Senior Commissioning/Validation Specialist

    Stantec (Raleigh, NC)
    …us create buildings that matter to our world. Together, we are enhancing the quality of life globally through design. Join us and design your place with Stantec. ... FDA or similar facilities where drug products are manufactured, stored in GMP conditions and distributed, including computerized and automated systems which require… more
    Stantec (11/06/25)
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