- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …procedures. Provide expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …system related issues and discrepancies. Relationships This position reports to a manager in Business Applications. The individual interacts with all levels of the ... meet the technical and functional specifications; assesses and develops validation requirements; conducts functional testing, performance testing and integration… more
- Tris Pharma (Monmouth Junction, NJ)
- Sr Project Manager , Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, ... timing + roles + responsibilities for prgms incl scale-up activities, process validation , post- validation changes + comm w/ FDA. Provide tech spt to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of the Biostatistics and Data Management ... teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesManage external vendors… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Provide expertise and solutions to CSV questions and issues. **Responsibilities** - Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer ... diseases and immune disorders. **Summary** Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Integra LifeSciences (Plainsboro, NJ)
- …candidate will act as liaison between the organization and the supplier to lead and communicate the component/process validation requirements and ensure timely ... demonstrate proficient experience with quality management concepts, IQ/OQ/PQ process validation and manufacturing engineering to drive continuous improvement. The… more
- TD Bank (New York, NY)
- …+ Generally leads a team focused on assigned audit and generally assumes the lead position on the audit, providing supervision and assignments to team members as ... status, and findings + Works at direction of Audit Manager + May perform testing procedures for more critical...in Charge on an Audit + May participate and/or lead assigned special projects + Provides feedback on staff… more
- J&J Family of Companies (Trenton, NJ)
- Senior Manager , Product Quality Management (PQM)-Excellence Lead - 2406187175W **Description** Johnson & Johnson is currently recruiting for a **Senior ... Manager , Product Quality Management (PQM)-Excellence Lead !** This...Strong understanding of software development lifecycles, including release and validation management o Experience in delivering validated software in… more
- WM (Trenton, NJ)
- …identity, age, national origin, disability, or veteran status. **I. Job Summary** The Sr. Manager , Talent & Learning Lead works in partnership with the business ... for employees across all Market Areas. + Along with the local HR, actively lead , consult, and collaborate on Market Area Talent Reviews and Succession Planning. +… more
- J&J Family of Companies (Trenton, NJ)
- …and inspections. Additionally, Quality Operations drives the acceleration of data-driven validation approaches for new technologies. The Senior Manager , Systems ... Senior Manager , System Development Governance - 2406186147W **Description** Johnson...encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services,… more
- J&J Family of Companies (Trenton, NJ)
- …audits and inspections. Additionally, Quality Operations drives the acceleration of data-driven validation approaches for new technologies. The Senior Manager of ... Senior Manager , Quality Ops Analytics Leader - 2406186163W **Description**...encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services,… more
- Lilly (Branchburg, NJ)
- …manufacturing operations and for the specification, installation, start-up and validation support of process equipment projects. As applicable, other duties ... prepare, and review Operational SOP's and Functional Requirement Specification (FRS), lead projects activities, and represent automation group in several process… more
- Taiho Oncology (Princeton, NJ)
- Sr. Manager , Analytical Development Princeton, NJ, USA Req #362 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... innovation thrives, and excellence is celebrated. As a Senior Manager in Analytical Development, you'll play a pivotal role...to drug substance and drug product, serving as analytical lead for assigned projects with the CMC team. Liaises… more
- Actalent (Basking Ridge, NJ)
- Description: + Clinical Data Manager who will work collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions ... with CROs performing data management tasks for assigned study. + Coordinate, lead and perform clinical data management activities for assigned studies in accordance… more
- Deloitte (New York, NY)
- Deep Learning Data Science Manager SFL Scientific, a Deloitte Business practice brings together several key capabilities to architect integrated programs that ... and enterprise value. We are hiring a Data Science Manager to support the technical design, development, and deployment...science & AI career. + Serve as the technical lead on projects to drive the technical strategy, roadmap,… more
- J&J Family of Companies (Skillman, NJ)
- External Quality Lead - 2407019664W **Description** Kenvue is currently recruiting for: **External Quality Lead ** **Who we are** At Kenvue, we realize the ... for you! Join us in shaping our future-and yours. Role reports to: Manager - External Quality Location: Skillman, NJ (Kenvue's corporate headquarters is currently… more
- J&J Family of Companies (Skillman, NJ)
- …- 2407020615W **Description** Kenvue is currently recruiting for: **Distribution Center QA Lead ** This position reports to Senior Manager Distribution and ... more information, click here. (https://www.youtube.com/watch?v=XhsbOsBiX\_M) **Role reports to:** Senior Manager Distribution and Supplier Quality CQ **Location:** Palmetto, Georgia… more
