- Sumitomo Pharma (Raleigh, NC)
- …(CDMOs). This role will serve as a leader and work with external manufacturing sites to ensure quality and compliance is met, provide technical oversight; ... https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The **Associate Director , Commercial Drug product Manufacturing and Packaging** is… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** TheSenior Director , Digital Process Development and MSATwill lead the strategic direction, full lifecycle management, and continuous ... digital transformation initiatives, andoptimizingtechnology solutions to enhance operational efficiency, compliance , and innovation in a regulated biomanufacturing environment. This… more
- Lilly (Raleigh, NC)
- …a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (eg filling ... increased technical capacity across the network. **Position Brand Description:** The Director /Senior Director , Global Process Owner for Sterility Assurance, as… more
- Merck (Wilson, NC)
- …successful completion of projects. This includes technical support to the internal and external manufacturing sites as well as Third Party Logistics providers to ... **Job Description** Reporting into the Director , Logistics and Distribution Technology the Associate ...expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and 3rd party logistics… more
- Merck (Wilson, NC)
- …candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, supply ... **Job Description** Reporting into the Executive Director Packaging Technical Operations the Director ...product container closure systems including mold qualification and regulatory compliance . To act as master data stewards and support… 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 ... professionals focused on manufacturing , automation, and quality systems. They will lead a...ensure the ongoing development of the team. The Associate Director , Operational Technology will maintain a strategic approach to… more
- Fujifilm (Holly Springs, NC)
- …ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain ... **Position Overview** ** Director , QA Drug Substance Operations** Are you a...managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and… more
- Fujifilm (Holly Springs, NC)
- …and executing Cleaning Validation (CV) activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 ... Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the… more
- Fujifilm (Holly Springs, NC)
- …including material science aspects, to ensure the robustness, efficacy, and compliance of manufacturing processes. his role requires strategic leadership, ... **Position Overview** The Director , Process Validation plays a pivotal role in...Ability to lead large meetings, including cross-functional groups and external partners + Advanced knowledge of Good Manufacturing… more
- GRAIL (Durham, NC)
- …overall leadership and implementation of GRAIL's Global Audit Management Program (Internal, External , Supplier) compliance designed to address all aspects of the ... as required to ensure a state of readiness. + Manage and support the external regulatory compliance inspections (CAP, NYSDOH, FDA, IVDR), responses, and action… more