- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... as needed. Continuously monitor and identify and implement improvements to the process. Support development of inspection readiness related training for GCO and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of GCO Onboarding training .-Assist with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as ... research areas centered around rare diseases and immune disorders.Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help … more
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …auditing and monitoring remediation, and support in developing guidance documents and training . The Manager , US Compliance reports to the Senior Director, US ... matters with discretion and judgment.Manages workload and work product to support Manager efficiently and in a solution-oriented manner.Excellent communication… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... in accordance with DS standards. Act as the project manager of the clinical study team to liaise and...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Aequor (Thousand Oaks, CA)
- …suppliers. At , our mission is simple: to serve patients. After virtual onboarding and training , the Capital Projects Sourcing Manager may be located at one of ... for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and… more
- Insmed Incorporated (San Diego, CA)
- …documentsKnowledge of analytical instrumentationExcellent critical thinking skills to support quality decision-makingExcellent written and verbal communication ... technical documentsKnowledge of analytical instrumentationExcellent critical thinking skills to support quality decision-makingExcellent written and verbal communication… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... and could include all or some aspects of the Quality function.The Product Development QA Manager provides...a representative for Catalent's strategic clients as well as support the clients with products that have technical opportunities… more
- Aequor (Thousand Oaks, CA)
- …of experience. Travel required about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a ... specific area(s) of responsibility FUNCTIONS: 1.Responsible for hiring, training , supervising and performance management of staff. 2. May perform or oversee the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the Center for Data Governance ... perspective. This person will report to the Associate Director, Training and Communication of the Center for Data Governance...Governance and work collaboratively with the broader team to support their efforts in other areas such as Data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …through costs.Ensure study budget is reconciled with Finance on an ongoing basis. Support all inspection readiness and quality initiatives pertaining to assigned ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and TLF standard, develop sample programs to generate standard ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in ... and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and ... within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the...and may also participate on a non-project initiative in support of these objectives. This position will report to… more
- Aequor (Thousand Oaks, CA)
- …features and capabilities. Develop business process and knowledge management framework to support change management and training needs. Develop proposal and ... understand corporate and functional prioritization approaches and data sources to support PD prioritization Organizational and business change management Ability to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as a shared services operation, meeting all deadlines and related responsibilities in support of the enterprise and the strategic vision of leadership while ensuring ... Procurement, Legal, IT and other departments, as required.- Oversees the training and revisions of all Financial Disbursements technology applications and other… more
- Insmed Incorporated (Bridgewater, NJ)
- …supply chain systems.Implement and maintain data governance practices to enhance data quality and reliability. Support maintenance of Item master and work ... materials, components and services consistent with specified levels of quality , delivery, price and total cost. This position will..., delivery, price and total cost. This position will support the Associate Director, Supply Chain & Logistics in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in ... such as Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports. Support the change management process for validated systems where necessary.Maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Tech Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and ... and compliance have been followed.- Contract Management/ Finance Liaison/ Internal Audit Support - Partner with DSI Finance Business Partner to maintain and track DSI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position Develop role-based training curricula for CMR function to ensure quality and compliance in accordance ... quality , and customer service. Essential Functions Ensuring CMR employees receive training on regulatory compliance, quality standards, GxP requirements and… more
