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Proven expertise in GCP/GMP regulations and standards, with a deep understanding of how these regulations apply to vendor management and quality assurance. Provide comment to Mural vendor management documentation including Quality Agreement templates, questionnaires etc.
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In this pivotal role, you will provide scientific leadership, people management, and strategic direction, ensuring the delivery of top-quality pathology services for our diverse portfolio of drug discovery and development programs.
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Job Description ASSOCIATE DIRECTOR, LEADERSHIP ENGAGEMENT AND VOLUNTEER DEVELOPMENT, Resource Development, to strategize and work collaboratively with the senior director to lead and direct the engagement and management of high-level volunteers and members of the MIT Corporation.
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Provide advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within the company (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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The position will also support the quality oversight of the Prescription Drug Marketing Act (PDMA) for the company's Commercial product Sample Management. The Director of CQPV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality oversight of the Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations that contribute to the PM PV safety data.
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Demonstrated experience in vendor selection and vendor management that deliver best-in-class quality/service at the lowest possible cost. The Director, Operations - Consumables requires a broad knowledge and experience across the end-to-end supply chain, along with strong negotiation and contract management skills.
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While technical digital skills like coding languages or front- and back-end development are neither required nor expected for this role, candidates should possess experience in digital content management tasks, including content scheduling, approval workflows, content archiving, metadata development, and SEO best practices.
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Job Overview: The Director, Clinical Operations will lead the clinical trial operations for their immunology program across all phases (I-III), ensuring successful collaboration and team management.
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Under the direction of the executive director, the Facilities Project Manager is responsible for safety, quality and budget for projects ranging in size. At Sodexo, we offer Facilities Management positions in Corporate, Schools, Universities, Government and Agencies, Healthcare and Senior Living locations across the United States.
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Job Summary and Role Purpose:To enhance the quality and integrity of patient care through 1) effective acquisition, management, and support of APRNs (with focus on clinical expertise support), 2) implementation of the organization’s clinical goals, procedures, protocols, and workflows in accordance with the Mission, Vision and Values for their designated region, and 3) clinical risk management and quality control.
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Demonstrated competency in ability to develop and implement strategy, people management, compliance and product quality achievement, mergers and acquisitions. Responsible for ensuring compliance with all global regulations and Sirtex Quality Management System.
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The relevant infrastructure will include elements such as an enterprise data catalog, data governance (including conventions and standards), data quality, master data management, application integration, data exchange, ETL/ELT, data modeling, and related components.
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Job SummaryReporting to the Global Project Head, the CRD leads clinical trial strategy and execution of assigned program(s) within the clinical development team, including interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan.
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The NHA also believes in fostering a vibrant community spirit, and its expanded is designed to enrich the lives of residents with high-quality social services and clinical case management.
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Director of Regulatory and Quality AssuranceGreater Boston ( hybrid role )The ideal candidate will have experience in the medical device regulatory industry with a proven record of successful submissions to FDA of IDEs, 510(k)s, and PMAs; international regulatory experience (Europe, Asia, South America);and a solid background in managing a high performing team and demonstrated success in product life cycle management.
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quality management jobs Title: director in Cambridge, MA
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