- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with stakeholders to ensure a compliant ready state of operation.Ensure that CRO/ Vendor quality events/ incidences are adequately reviewed and CAPAs followed up ... research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and collaborates with cross-functional teams to ensure rapid response to any quality concerns, audit findings, or vendor performance problems Develops and ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....to date on current industry practices around contracting and vendor compliance to contract requirements Builds efficient and effective… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis, supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ... and procurement - to develop criteria and best practices for vendor selection.Establish and/or approve internal and external policies, standards, and processes… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality ... certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance. Essential Functions Reviews all manufacturing and support records to… more
- Merck & Co. (Rahway, NJ)
- …LATAM regional lead for Technology Procurement manages commodity and vendor ownership -within IT professional Services, Software, Hardware, and Telecom ... - Drive competitive sourcing events (RFQs, RFIs, RFPs) and support vendor selection, commercial negotiation, and market awareness.Relationships - Build outstanding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical ... data by ensuring all clinical & companion diagnostics data meet quality requirements and protocol defined analysis endpoints (primary, secondary, exploratory, etc.).… more
- Eisai, Inc (Nutley, NJ)
- …clinical practice (GCP) and specific country regulations such as site and vendor selection, preparing clinical trial budgets. Ensures study is conducted within ... reviews, reconciliation and study file archival Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision… more
- Merck & Co. (Rahway, NJ)
- …Intelligence (CTI), to include intelligence collection, curation, management, analysis standards, quality control, and dissemination of finished products to a wide ... information based on our Company's Intelligence Requirement Framework from open source, vendor collection, and internal tooling to identify threat intel and cyber… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple sources of data. Responsible for prioritizing team activities and managing quality of the deliverables. Oversee the support and operations of production ... loads, communication on issues and resolutions to DSI.Support the analysis of the vendor (s) monitoring tool(s) that are used to manage, run, notify, and report… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with vendors. Ensuring that the terms and deadlines are met. Evaluating vendor performance, assessing spend, maximize value from vendors, ensure service quality ... efficiency. Mitigate potential risks, including any third-party disruptions.- Evaluate current vendor processes and systems for continue to enhance programs. - Legal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …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 ... Legal, Global Development and R&D Finance Accountable for all aspects of vendor management for assigned trials, effectively negotiates third party clinical contracts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …works closely with statistical programmers in statistical analyses execution, quality control, and data derivation; collaborates closely with data manager ... to ensure high quality data. Work closely with internal statistical programmer.Global strategy...cost savings and shortened timelines for the company.CRO / Vendor Oversight: Review CRO/ vendor proposal and budget.… 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 risks ... and approvals and associated interactions with vendors. Supports regular vendor /sponsor discussions to identify risks and ongoing study support. Identifies… more
- Aequor (Devers, TX)
- …improvement of process automation systems, MES, LIMS, application integrations, local manufacturing, quality control and quality management site IT systems as ... service level management scope and process with IT groups and/or vendor managed services, ie Service Level Agreements (SLA's), Disaster Recovery/Service Continuity,… more
- BioAgilytix (Durham, NC)
- …frameworks, including FDA, GLP, GxP, and Part 11.o Partner with BioAgilytix's Quality and Regulatory teams to support validation, documentation, and audit readiness ... for all system and integration processes. Vendor and Stakeholder Managemento Serve as the primary liaison between BioAgilytix and LabVantage, managing support… more
- Genmab (Plainsboro, NJ)
- …integrity, consistency, and adherence to standards, and ensuring well-structured, high quality data summaries for internal decision making and reporting to health ... doing the same.Performs database consistency checks on databases delivered by vendor .Performs sponsor oversight of programming activities performed by vendor… more
- Merck & Co. (North Wales, PA)
- …Data Visualization, Field Intelligence, you will design and development of high- quality compelling data visualization products to drive programmatic decision making, ... projects and processes within Sales, Marketing, and Operations TeamsChampion data quality , integrity and reliability throughout the department by designing and… more
- Merck & Co. (Durham, NC)
- …procedures to resolve process/equipment issues, minimize downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive ... team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. - Primary activities for this position… more
- Merck & Co. (Rahway, NJ)
- …and publications.Responsible for study-related contracting, budgets, and vendor /partner management.Develop American Managed Care Pharmacy (AMCP) dossiers ... outcomes instruments for inclusion in clinical trials and disseminate health-related quality of life results in collaboration with internal teams and external… more
