- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for ... to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are PV relevant and AE reporting language ... with CROs, License Partners, and PV vendors.Assist with PV oversight of the DSI Call Center.Manage oversight ...PV oversight of the DSI Call Center.Manage oversight of ICSR processing activities including, Safety Information submission… more
- Eisai, Inc (Nutley, NJ)
- …Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system. This role is responsible for ... role is responsible for leading the digital transformation to enhance current quality oversight capabilities and knowledge within CQA and Eisai. This is a high… more
- Merck & Co. (Rahway, NJ)
- …proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.The incumbent will be ... through the study lifecycle. The CQOM is accountable for ensuring comprehensive oversight of all activities delegated to third parties.-This will include, but not… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer ... requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provides strategic leadership in Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of ... encountered at the department level.- Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (eg, operational leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review, documentation reviews in collaboration with the ICSR management and CRO/Vendor oversight groups for case processing activities and reports to the Director of ... case processing issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards Oversight : Acts as subject matter expert in ICSR standards,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and ... company policies, procedures, and all applicable regulations.Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing… more
- Aequor (Thousand Oaks, CA)
- …- with a clear mandate to deliver measurable improvements in supplier oversight and business outcomes. Strategic Impact Enable digital optimization in supplier ... dashboards/visualization tools by stakeholders. Measurable efficiency gains in supplier oversight workflows. Expansion of SMPA digital support model to additional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …associated policies, charter and procedures, as applicable.On a daily basis provide total oversight on the processes relating to the conduct of signal detection via ... and applicable ICH/GCP guidelines to ensure patient safety for company's products.Provide oversight over compliance activities and fosters a culture that seeks to… more
- Merck & Co. (Rahway, NJ)
- …from early development through lifecycle management, providing critical technical strategic oversight and guidance across all teams involved in the development and ... regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical Strategic Oversight :Provide deep subject matter expertise in the design, development,… more
- Twist BioScience (South San Francisco, CA)
- …market dynamics to offer guidance to hiring managersProvide recruiting program oversight with planning and implementing successful recruiting strategies ie diversity ... market dynamics to offer guidance to hiring managersProvide recruiting program oversight with planning and implementing successful recruiting strategies ie diversity… more
- Eisai, Inc (Nutley, NJ)
- …Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good ... Clinical Practice (GCP) oversight , and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies,… more
- Genmab (NJ)
- …a solid scientific foundation existsEnsure proper documentation of work doneKeep oversight and QC essential documents/data provided by vendorsEnsure trial related ... BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable SOPsGive input to eCRF setup, edit… more
- Tris Pharma (Monmouth Junction, NJ)
- …warehousing, logistics, etc.) to ensure day to day management and oversight of company's supply chain, logistics and inventory levels across organization ... supplier performance and conduct regular business reviews; Provides guidance and oversight for new sourcing, contracts, service agreements and capital equipment… more
- Merck & Co. (North Wales, PA)
- …prior experiences to a new challenge. Project consultation with supervisors, rather than " oversight " is expected at this level. In addition, the Director may be ... expected to take on one of the following important responsibilities: 1) mentoring/coaching other PMs, including understanding their projects and developing their knowledge of drug/vaccine/biologics development, governance & team processes and PM skills; 2)… more
- Merck & Co. (Rahway, NJ)
- …pipeline, plus growth of existing products. This position will involve oversight of late-stage method development, validation, and life-cycle management of methods ... but mainly global method transfer activities.Within the Global Quality Large Molecule Analytical Sciences (GQ- LMAS) organization, this Analytical Transfer Team include activities interfacing with a global network of product manufacturing and testing sites,… more
- Aequor (Thousand Oaks, CA)
- …and Performance Analytics (SMPA) will play a key role in the oversight and performance management of outsourced services supporting 's Research and Development ... (R&D) organizations. This position is responsible for driving quality and ensuring stability across a global network of external third-party providers, with the ultimate goal of maintaining a robust and healthy supplier base capable of supporting the full… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Marketing and Omni-Channel Strategy, including all budget-related, project management oversight and other issues. Oversee the print channel to ensure effective ... dissemination of all communication and tools meet the internal customer expectations. Work with IT to manage user experience across platforms, assisting with problem resolution. Act as a champion and change agent in leading the organizational changes required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …budget, resources, algorithms, projections, risk management and mitigation. Operational Oversight and Reporting: Oversee the management of QA shared resources, ... ensuring accuracy and timely updates of information related to ongoing activities. Produce and deliver accurate reports and documentation related to Global QA activities in collaboration with relevant stakeholders. Qualifications: Successful candidates will be… more
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