- Daiichi Sankyo, Inc. (Bernards, 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
- 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: ... execution of capital projects, in a sourcing or procurement lead role or another role on the project team?...the largest project? (5) During the interview with hiring manager , you will be asked to walk through the… more
- Aequor (Thousand Oaks, CA)
- …cGMP equipment and facilities at Thousand Oaks (ATO). The engineer will lead project engineering and construction activities in alignment with the engineering ... works in partnership with the maintenance, Project Management, Engineering Technical Lead , and manufacturing to develop and oversee the operation and reliability… 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 ... compliance across the organization.Job Responsibilities:Leadership & Management: Create and lead the IS Quality function, providing strategic direction and ensuring… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Lead Maintenance Technician is a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in ... supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. The … more
- Merck & Co. (Durham, NC)
- …peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements. ... - The Lead Maintenance Technician is responsible for providing equipment troubleshooting,...by policies, procedures and business plan; receives guidance from manager Manage multiple priorities and advance several tasks in… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT to implement and maintain Eisai's ... aid in delivering an inspection ready TMF. The Sr. Manager will be required to work collaboratively with group...both locally and globally. This role will identify , lead and participate in TMF system and process improvement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role ... OverviewThe Warehouse Operations Manager will work within Technical Operations and be responsible...solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity,… more
- Eisai, Inc (Nutley, NJ)
- …evolving regulatory requirements, user needs and business and functional requirements. Lead the development, support and rollout of relevant technologies and ... Experience in managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP policies and /or Regulatory Controls (eg,… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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
- Aequor (Thousand Oaks, CA)
- …This team works with pre filled syringes 20% and 80% auto injectors. Manager would like to see writing samples if available. Successful candidate understands human ... autonomously. Is a critical thinker, detail oriented, and a great communicator. Manager prefers Bachelors or greater in human factors engineering or biomedical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead ... Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports… more
- Raytheon (Tucson, AZ)
- …five (5) years of relevant experience Experience leading efforts as a program manager , IPTL, sub-IPTL, REA and/or project team lead . Experience with financial ... needs a Senior Principal Systems Engineer Integrated Product Team Lead who can lead a section of...design with transition to the factory, and verification / validation of product hardware using proven test systems, methodologies,… more
- Qualcomm (Austin, TX)
- …are seeking an ambitious, technically strong, innovative and hands-on manager to lead the Cloud AI accelerator card validation team. Job activities span the ... Engineering, or related field and 4+ years of ASIC design, verification, validation , integration, or related work experience. OR Master's degree in Science,… 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
- Teva Pharmaceuticals (West Chester, PA)
- …support of a biologics manufacturing facility and associated laboratories. The Sr. Validation Lead will serve as project manager and lead validation ... teams focused on commissioning and qualification activities. * Serve as lead validation engineer and project manager on commissioning and qualification… more
- Kelly Services (Chesapeake, VA)
- …the largest machinery manufacturers in Japan. **Responsibilities:** The Engineering Standards and Validation Manager will lead efforts to standardize ... **Position Title:** Engineering Standardization & Validation Manager **Location:** Chesapeake, VA, 23323...technical processes and procedures to optimize engineering activities. This Manager will lead the ESV Team to… more
- Reynolds American (Winston Salem, NC)
- …for a Validations Compliance Manager ** **in Winston Salem, NC** The Validation Compliance Managers lead the validation processes, policies, execution ... Validation Compliance Manager (Process Validation...across RAI Operating Companies. The position is responsible to lead /manage standardization, develop framework and processes for validation… more
- Citigroup (Tampa, FL)
- …Risk, and Compliance, etc. The Data Lineage and Modeling Validation and Support Lead will lead validation of Data Lineage and Modeling across SMC's ... The Data Lineage and Modeling Validation and Support Lead is a...stakeholders, senior management, and IT partners + Experience as Manager with directing subordinates' including providing direction, performance reviews… more
