- Merck & Co. (Rahway, NJ)
- …strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and provide US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process ... assets within the alliance by effectively liaising, negotiating, and partnering with FDA . This role will create and implement effective regulatory strategies to… more
- Aequor (Thousand Oaks, CA)
- …any time zone OK Does the thought of building an entirely new digital quality management system, excite you? Do you love to design and streamline processes within ... a hard-working team? If you have a passion for streamlined, user-friendly Quality Management System enabled by digital and want to be part of 's mission to serve… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the Quality Department in developing and ... Position Summary:The Quality Execution Counsel is a managing member of...uniquely Exela's way. Job Responsibilities: Drafting, editing, and reviewing FDA -issued regulations and Guidance documents, as well as internally… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lead who is responsible for ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly motivated ... can work cross-functionally to innovate and increase operational efficiency, allowing quality monitoring activities to scale as the organization and contact volume… more
- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Senior Specialist, Quality Control participates in a team of analysts in the development, ... validation, equipment validation, and GMP laboratory readiness.- The Senior Specialist, Quality Control will be responsible for starting testing in new laboratories… more
- Twist BioScience (South San Francisco, CA)
- We are seeking a highly experienced and motivated Staff Quality Engineer join our dynamic team. As a Staff Quality Engineer, you will be responsible to ensure ... and surveys. You will also be responsible for developing and implementing quality metrics (KPIs) to track and improve customer satisfaction. Additionally, you will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Quality Control Testing Scheduler as part of the Quality team based in ... organized QC Testing Scheduler to join our team for Quality Control. The ideal candidate will manage and maintain...industry is required.Knowledge of cGMP and GDP regulations and FDA /EU guidance related to manufacturing of cell-based products is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... Independently lead cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategize and plan for FDA … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary Effectively liaise, negotiate and partner with FDA ; direct, coordinate and implement the preparation of all regulatory submissions ... meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH Guidelines, and GCPs governing the conduct… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …electronic quality systems and SAP.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell-based products as well as knowledge ... Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level position is responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....clinical trials In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV relevance for ... with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers. Develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ManagementManaging ... report output.For all data requests, perform self-QC of data to ensure quality of results. Service Provider Oversight & ManagementOversight of Data Request… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe QC Chemistry Finished Product Supervisor will report directly to quality upper management, (QC Senior Manager), and will provide both managerial ... methods for raw material, in-process, and finished product per USP and FDA guidanceProvides work assignments with communication of the expected timelines to… more
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