- Eisai, Inc (Nutley, NJ)
- … Manager (CISM) certification is essential. Additional Certified Information Systems Auditor certification is advantageous.ISO 27001:2013 Lead Implementer ... hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio of IT Compliance… more
- BioAgilytix (Boston, MA)
- … Systems Administrator will ensure smooth, compliant, and effective system operation, providing ongoing support and optimization for these essential ... while ensuring compliance with industry regulations and standards.Support and system administration for identified applicationsPerform *and lead investigation… more
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Aequor (Bothell, WA)
- …local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as ... working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and global applications used within… more
- Merck & Co. (Upper Gwynedd, PA)
- …clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.Expert knowledge of ... clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Eisai, Inc (Los Angeles, CA)
- …Job Summary: The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The ... (S-suite, C-suite, KOLs, Pathway and P&T committee members). Each ABL will lead account responsibility for a defined number of potential strategic accounts and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and change management initiatives. Also responsible for expense or headcount control procedures and management reporting capabilities. Develops and maintains a ... - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase...always maintained and accurate. Accountable to the Global Team Lead (GTL) and GPT (Global Project Team) for the… more
- Merck & Co. (Rahway, NJ)
- …teams to ensure quality integration into product design and development processes (Design Control per ISO 13485, QMSR, Part 4). Lead quality oversight of product ... complex medical devices, including auto-injectors and other innovative drug delivery systems associated with combination products. This role ensures the highest… more
- Merck & Co. (Rahway, NJ)
- …an acceptable risk posture. Define the requirements, best practices, and lead the collaborative development of cloud system /service architecture, design, ... in cloud infrastructure, applications, services, and for information traversing our eco- system . Work closely with DevOps teams on Infrastructure as Code, Automation,… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …neuropsychological assessments, 3) Analyzing data to assure data integrity, quality control and protocol compliance, 4) Training and supervising research staff and ... Opportunities are also available to become involved in and/or lead research papers and publications. The majority of time...as well as the ability to learn department-specific computer systems as needed. Must have a high degree of… more
- Merck & Co. (Rahway, NJ)
- …of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.Adaptability and ... tight timelines, in a rapidly changing environment.Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or Global project teams. This position has advanced skills in technology systems , including word processing software and data management software, and business ... data is current and accurate- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA), Collate...and maintain all auditable documentation as per DSI Internal control - Support the Head Global QA strategy and operations… more
- Merck & Co. (Rahway, NJ)
- …(DC) and Design Verification (DV) deliverables across development to commercialization.Responsibilities: Lead a Center of Excellence (CoE) focused on developing and ... development, IND-enabling stability, commercial stability (PSS), and Design Verification (DV). Lead method tech transfer strategy and execution to internal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …instructions.Develop positive relationship with the QA team, Quality Control , Information Technology, Maintenance, Manufacturing personnel, Technical Operations ... GMP decisions.Independently resolves problems through the use of quality systems .Develop improvement ideas and independently implement associated solutions.Support QPIP… more
- Everglades Equipment Group (Orlando, FL)
- …to the Service Department o Opens work orders as directed by the Aftermarket Manager/ Lead or Shop Foreman and maintains control until they are closed and ... up and ordering of Parts for John Deere equipment using JDPOINT ordering system & PMPRO catalog system o Look up and ordering of Parts for Other Vendors using… more
- BioAgilytix (Durham, NC)
- …will lead and manage cross-functional IT projects spanning business systems , laboratory systems (ELN, LIMS), and IT hardware/software implementations. You ... internal stakeholders across IT and business units to ensure the IT systems and infrastructure effectively support the specialized needs of the company.Essential… more
- Merck & Co. (Millsboro, DE)
- …leadership of the Animal Services Department.Essential Duties / ResponsibilitiesAssociate Director: Lead and develop a team of animal care and testing ... Senior Leadership Team for the Millsboro, DE biologics manufacturing site. Lead numerous projects including process improvement and safety initiatives.Coordinate /… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturingCleaning and facilities managementProficient with Manufacturing Execution System (MES)Quality Management knowledge, including Change control ... to ensure the facility meets aseptic requirements for Manufacturing and Quality Control Labs. This person will communicate and provide updates 1st shift facilities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality, governance needs and dealing with all data interconnectivity with other systems .Build and drive plans to improve data practices for operational, reporting ... and analysis needs - Inclusive of development of processes, control and best business practices around data management.Build organization understanding of data… more
