- Eisai, Inc (Nutley, NJ)
- …This role is responsible for leading the digital transformation to enhance current quality oversight capabilities and knowledge within CQA and Eisai. This is ... strategy including audit and inspection management, issue management and oversight of the Quality management system. This role is responsible for Good Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves ... tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, ... development of validation and qualification related policies, procedures, templates, formsProvides quality oversight on data integrity of systems, instruments,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical ... compliance within company policies, procedures, and all applicable regulations.Key Responsibilities Provide Quality oversight of all aspects of the cell therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that ... seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...environment. The ideal candidate for this role demonstrates the quality mindset to strive for excellence, continuous improvement and… more
- Eisai, Inc (Nutley, NJ)
- … Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for ... profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance...Good Clinical Practice (GCP) oversight , and for assuring the compliance of projects, products… more
- Merck & Co. (Rahway, NJ)
- …embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.The incumbent will be ... parties.-This will include, but not be limited to:Facilitating and monitoring CTT oversight of vendorsDevelopment, review and revision of quality agreements with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …against service level and KPIs.Manage the development of governance, business continuity, quality , and vendor monitoring plans. Maintain oversight for capability ... agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are PV relevant and AE reporting language… 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 ... development of group members and also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and leads the execution… 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 ... as well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg, disproportionality assessments).This… more
- Merck & Co. (Rahway, NJ)
- Job Description Global Quality Large Molecule Analytical Sciences (GQ- LMAS) - Analytical Transfer Team Our Manufacturing Operations teams are the people that make ... our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… 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
- 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 ... to ensure continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross functionally with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines.A key focus will be the oversight of and interactions with CROs and other external vendors to ensure ... studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This...as our Network sites) and drive the CRO to quality , cost, and shortened timelines wherever possible. The ED… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, ... and all applicable regulations.Key Responsibilities Lead the team responsible for QA oversight of final CAR-T product batch record review and release practices.Lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy manufacturing processes. This role ... analysis, impact assessment, and CAPA/EC determination.Work cross functionally with SME's and Quality to ensure robustness of investigations, as well as accuracy and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliant facility operations according to cGMP requirements. This individual will provide oversight for a team of maintenance specialists and partner with cross ... facility emergency response plans and other required safety programs. Supports Quality driven initiatives related to facilities work such as change control,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team, developing standard approaches that foster a reputation for outstanding quality , collaboration, rigor, and follow-through. Collaborate with the Head Global RD ... and present to the Global Head of RD, PV QA/Vice President of Quality . Facilitating leadership meetings as needed and ensure timely delivery of presentations and… more
- Insmed Incorporated (San Diego, CA)
- …lead the central messaging, preparation, and submission of high quality , regulatory complaint regulatory dossiersDirect hands-on experience with key regulatory ... outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of Regulatory Affairs, lead the development and implementation of… more
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