- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, ... delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality ... responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance , the Director of Clinical ... and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical ...use and provides direction, guidance and strategy for company Quality Assurance .Full understanding of and practical experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and implement ... appropriate, data delivery and reporting.Accountable for the effective support of clinical activities within the Development organization.Ensure a " Quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is...service providers and working with internal departments to progress clinical supply projects. Every effort has been made to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role...or cell therapy.Experience with quality support in clinical manufacture is preferred.Flexible to work on weekends, as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... seeking QA Validation Specialist I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... quality , proactively identifying and resolving issues throughout the clinical trial process. Customer Focus / Stakeholder:Engagement Lead the implementation of… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and… more
- Merck & Co. (North Wales, PA)
- …team.Experience in CDISC and ADaM standards and demonstrated success in the assurance of deliverable quality and process compliance also required.Must possess ... quality , compliance and timeliness requirements.Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH and… more
- Merck & Co. (North Wales, PA)
- …anticipate stakeholder requirementsPreferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Merck & Co. (Rahway, NJ)
- …and tracking performance against forecasts.Collaborate with cross-functional teams, including quality assurance andregulatory affairs, and operations, to ... and benefits DD&T lab operations.Collaborate across DD&T sub-functions, regulatory affairs, quality assurance , Pharmaceutical Operations, Analytical R&D, and ITa… more
- BioAgilytix (Boston, MA)
- …procedures. Maintaining paper and electronic records of test results.Complying with quality assurance procedures, participating in proficiency testing and ... BioAgilytix Diagnostics is CLIA-certified, CAP-accredited, New York State licensed clinical diagnostic testing facility providing esoteric testing services to the… more
- Formation Bio (New York, NY)
- …obligations to maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of ... related professional experience required.Must have professional experience Project Management, Clinical Supply Management, and/or Clinical Trials CoordinationDemonstrated… more
- Merck & Co. (Rahway, NJ)
- …advisor for all teams working on Autoinjectors, fostering collaboration among engineering, quality assurance , regulatory, and manufacturing teams across the CMC ... Manufacturing divisions.Interface with external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance,… more
- Terumo Neuro (Aliso Viejo, CA)
- … Assurance **Job Description:** Provide support to all aspects of the Clinical Quality Assurance (CQA) function across the business. Support CQA ... in establishing and maintaining metrics reporting to reflect effectiveness of Clinical Quality Assurance . + Comply with applicable Laws and Regulations,… more
- Access: Supports For Living (Middletown, NY)
- Clinical Quality Lead - Quality Assurance Location: Middletown, NY, United StatesDate Posted: Sep 12, 2025 Share: share to e-mail Apply Now Save JobSaved ... Lead is critical to the successful expansion and transformation of the agencies Quality Assurance and Quality Improvement efforts to enhance the services we… more
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