- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with legal and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU Medical Affairs ... and metrics. Support continuous process improvement, interpretation of regulations, quality and compliance with regulations and company standards,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary: Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS Quality function. The ideal ... Assurance department and cooperation with various stakeholders to enhance quality and compliance across the organization.Job Responsibilities:Leadership &… more
- Aequor (Tallahassee, FL)
- …and case quality including analysis and reporting of trends in quality measures Ensure vendor compliance with approved processes and training requirements ... Flex, normal dayshift hours Title (Role) Case Management - Manager Organization Global Patient Safety Intake Call Notes with...Summary Responsible for: Support ICSR processing to ensure high quality cases in a timely manner to meet all… more
- Insmed Incorporated (San Diego, CA)
- …a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... Manager , you will be responsible for the daily oversight...stability and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance, Manufacturing and CMOs, Material Management, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... Essential Functions Manage the maintenance and implementation of safety programs, compliance plans, and initiatives with primary focus on laboratories as well… 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 ... difference? The Position The Manager , Digital Transformation will drive execution of Novo Nordisk, Inc. (NNI) CMR digital initiatives. Incumbent will be responsible… more
- Aequor (Austin, TX)
- Remote - EST or CST time zone preferred. MANAGER IS OPENING CAP, PLEASE SUB AT MARKET RATE! CANDIDATES MUST COMPLETE THE PRESCREENING QUESTIONS FOR REVIEW ON RESUME: ... was the dollar value of the largest project? (5) During the interview with hiring manager , you will be asked to walk through the specific steps in Ariba that you… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... ensure the adherence to the Quality Manual. Responsible to ensure efficiency, accuracy and standardization...in connection with contract testing laboratories to ensure the compliance for products marketed and/or distributed locally. May author… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tools to achieve excellence in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational ... support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... trends, and variances to ensure acceptable business practices, procedures and compliance have been followed.- Contract Management/ Finance Liaison/ Internal Audit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure all systems are operating well as designed. Ensures compliance with internal controls and accounting policies. Optimizes Financial Disbursement technology ... Ensures all systems and data operate and are maintained to the agreed quality and service requirements- Leads the planning and deployment of system upgrades,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.Procedure Development: Supports the ... as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.Global Clinical Study Start-Up… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor performance, assessing spend, maximize value from vendors, ensure service quality . Reduce costs without compromising quality . Monitor projects and ... processes and systems for continue to enhance programs. - Legal and Compliance Management- Manage and oversee complex processes for approval of material within… more
- Aequor (Thousand Oaks, CA)
- …The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance . The position will support the projects ... to have process/utility Engineering technical experience and not only be quality background driven. This engineering position supports projects that associated with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. ... trouble shooting and resolving complex scientific / technical problemsDevelops and evaluates quality processes and system standards to ensure compliance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring ... ensure business objectives are met Manages and monitors organizational compliance with all established supplier agreements Provides strategic procurement… more
