- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. ... Role OverviewThe Quality Compliance Manager is responsible for regulatory ...required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of… more
- Merck & Co. (Durham, NC)
- …activities requiring support include the process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of ... assignments. Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Functions Oversee performance of CROs, third party vendors, and contractors, including co- monitoring , to ensure compliance with study protocol, and identifying ... We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work...Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... and agencies. Ensure quality control of marketing content in alignment with compliance Continued Improvement: Ensure pull-through of 'test and learn' principles by… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP CX Manager -CV/Renal will be a critical driver in ensuring the successful execution of brand/therapy ... material. Ensure quality control of marketing content in alignment with compliance standards Continued Improvement: Ensure pull-through of 'test and learn'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs), ... Oncology and Specialty Medicine strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and...the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for study committees (eg, Executive Committee). Provides input to Clinical Operations on monitoring plan (eg data fields to be SDV'd) and to Biostatistics on ... (SAP).Study execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership ... approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to ... support process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product.- The focus for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities Prior TMF… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal affiliates, CROs, third party vendors, and contractor to ensure compliance with study protocol. Resolves or escalates major/cross-program issues, supported ... project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment Categorization Tool (RACT) Ensure country… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... media relations, internal communications, public disclosures, social media policies, compliance , crisis communications, and diversity initiatives. Develops contract templates,… more
- Merck & Co. (Durham, NC)
- …microbiological testing; evaluation of environmental microbiological samplesConducts environmental monitoring sampling to include active air and surface sampling ... alignment with department objectivesConducting In-Process and Release testingConducting Environmental Monitoring of processes and on a routine basisProblem SolvingIdentifies… more
- Merck & Co. (Durham, NC)
- …for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.Responsible for ... IQ/OQ/PQ).Review and approve Performance Qualification documents pertaining to environmental monitoring and process qualification.Provides Quality input, direction, and approval… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The QC Microbiology Supervisor leads, and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, you will implement ... performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Product Supervisor will report directly to quality upper management, (QC Senior Manager ), and will provide both managerial and scientific (hands on) leadership as ... will be responsible for establishing testing timelines, executing the plan and monitoring the results. The incumbent will be responsible for leading and developing… more
- One Medical (Rochelle Park, NJ)
- … Manager , support quality health outcomes, patient safety, regulatory compliance , and implement improvement initiatives to manage population health Use impeccable ... will motivate, support, and under direction of your Operations Manager , provide direction, and coach your teammates to ensure...practice through regular team check ins, review of staffing, monitoring of task queues, adherence to standard work, and… more
- LA Care Health Plan (Los Angeles, CA)
- Manager , Compliance Monitoring Job Category: Administrative, HR, Business Professionals Department: Compliance Location: Los Angeles, CA, US, 90017 ... support the safety net required to achieve that purpose. Job Summary The Manager , Compliance Monitoring serves as a leader within the Corporate Compliance… more
- Discover (Riverwoods, IL)
- …brighter financial future with Discover. **Job Description:** **What You'll Do** **The Senior Manager - Compliance Monitoring and Testing is responsible for ... administering and executing the Compliance Testing Program within Corporate Compliance . The program is designed to promote compliance with applicable laws… more
