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Oversees Inspection Readiness activities in collaboration with business and Quality Assurance partners related to research, GLP, biomarkers, IVD development activities. Oversees and assures timely and effective communication of summary trending and other insights on the quality of delivery in research, preclinical, biomarker, IVD work, and vendor performance to relevant business and quality leaders and in relevant forums.
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The Senior Director Quality Engineering will be accountable for the development, execution, and delivery of quality strategies for DPS TECA and Mitek Sports Medicine lifecycle management (LCM) and new product introduction (NPI) engineering activities.
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Assists in the development and maintenance of a detailed schedule of QA/Reg milestones and deliverables; to include internal audits, quality improvement projects, Trial Master File (TMF) reconciliations, etc.
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Provide key financial support for potential business development and partnering opportunities for preclinical-stage assets and/or research collaborations. Strong ability to implement best practices in back-office operations; commitment to continuous process improvement while managing costs, improving quality, and managing risks.
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Roadmap and strategy development, business case development expertise. Where possible, ensure development of attributes and MDM reference data is aligned with healthcare data best practices (FHIR, HL7, DaVinci, etc.
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The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
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These activities include the operational quality oversight of the clinical development programs specifically within our Cell and Gene Therapy (CGT) Disease Areas of the clinical portfolio.
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Reporting directly to the VP, Strategy & Business Development for Water Quality, and working with various strategic partners across six operating companies and the wider Veralto Strategy and Corporate Development organization, this highly visible role is instrumental in shaping the strategic direction and inorganic growth trajectory of the business and driving shareholder value.
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With a combination of industry-leading tools, services, and expertise, only Synopsys helps organizations maximize security and quality in DevSecOps and throughout the software development life cycle.
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Lead development of digital architecture blueprint, technical roadmaps, technology frameworks for software, data, integrations and infrastructure solutions Lead proposals for Digital Transformation and Cloud Computing and High-Performance Computing RFPs Provide thought leadership on Digital architecture roadmap to Business and IT leaders and enterprise architecture teams.
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The Robotic Process Automation (RPA) Business Analyst will be responsible for enabling high-quality business automation solutions in an Agile framework that delivers valued business outcomes and informed decisions for Zelis.
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As the Chief Engineer, you will function as the hands on supervisor while ensuring that the onsite maintenance team/technicians deliver quality services that continue to keep Bozzuto managed properties and outstanding place for residents to call home and for retail and commercial tenants to do business.
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BS in a scientific or engineering discipline with minimum of 8 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility, with at least 2 years conducting internal and external audits.
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Collaborate with operational and business partners on enterprise-wide research, clinical and quality initiatives to enhance Optum impact in the Radiation oncology field. Demonstrated accomplishments in the areas of medical care delivery systems, utilization management, case management, disease management, quality management, product development and/or peer review.
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You are able to assess business needs with respect to analytics, business intelligence, and tooling and effectively prioritize those across the business as we establish our workloads and the priorities of the external development teams that support us.
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business development quality jobs in Woburn, MA
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