- 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
- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer ... candidate will report to the Associate Director, Laboratory Operations to lead start-up new laboratories for microbiological testing and environmental monitoring.-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. 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
- Aequor (Thousand Oaks, CA)
- …meet milestones on time. The qualified candidate will support verification, validation , and regulatory submissions of these devices. Work within a cross-functional ... continuously integrate for predictable execution and teamwork across all functions.Responsibilities: Lead medium/small projects independently and work directly with Program… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... Leadership Team members, and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA practices to ensure… more
- Aequor (Louisville, KY)
- …onsite. *Shift will be Monday-Friday, 8 AM - 5 PM Feedback from hiring manager intake: Preferred Candidate Qualities - Analytical thinking What stands out on resumes ... Minimum Education - Bachelor's with 4 years of experience C&Q Project Manager ?Responsible for managing the Commissioning and Qualification (C&Q) strategy or main… more
- BioAgilytix (Durham, NC)
- …21 CFR Part 11, with a focus on data integrity and validation .Post-Implementation Optimization: Provide ongoing support and lead continuous improvement ... The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation,...focus on regulatory compliance and lab efficiency.Key ResponsibilitiesProject Leadership: Lead the onsite planning, execution, and monitoring of the… 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
- BioAgilytix (San Diego, CA)
- …LIMS systemServe as lead scientist on assay dev projectServe as lead scientist on validation or qualificationPresent data to clientsIndependently write plans ... to the patients who need them.Essential ResponsibilitiesServe as Bioanalytical Project Manager (BPM)/Principal Investigator (PI) on a projectMay prepare and submit… more
- Genmab (Plainsboro, NJ)
- …expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible ... contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the operation of the area Support evaluation, specification, installation, and validation of new manufacturing equipment as needed Maintains validated systems and ... re-validates existing systems in accordance validation procedures Incorporates value improvement programs and new processes from Product Support, Engineering, EH&S,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with relocation assistance eligible for selected candidate. Relationships Reports to: Manager of cLEAN & Training Number of subordinates with direct/indirect ... interact with external vendors in coordinating solution development and deployment. Will lead projects with indirect reports through the use of matrix management.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development, analysis files development, data surveillance review, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as ... analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Genmab (Plainsboro, NJ)
- …integral part of the product roadmaps and planning and embed code validation services in POD processes.Security Awareness: Actively promotes information security and ... TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as Leadership Team of IT&D, POD Managers,… 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
- 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
- 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
- Bristol Myers Squibb (Indianapolis, IN)
- …global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio's ... of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies. + Draft and review of Computer… 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
Related Job Searches:
IP Validation Manager Lead,
Lead,
Lead Manager,
Manager,
Validation,
Validation Lead,
Validation Manager