- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation or… 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 ... to work cross-functionally with existing Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using… 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 ... functions.Responsibilities:Lead medium/small projects independently and work directly with Program Manager on large multi-year programs. Managing the overall program… 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
- 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 ... attain resources and information from established internal contacts; consult with manager for decisions outside of established procedures.Provide direction to the… 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)
- The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information ... CFR Part 11, with a focus on data integrity and validation .Post-Implementation Optimization: Provide ongoing support and lead continuous improvement initiatives 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Closely collaborates with Digital on digital transformation projects and technology validation . Closely collaborates with Global System teams on platform feature ... enhancements, version releases, etc. Physical Requirements 0-10% overnight travel required. This is a hybrid role requiring 3 days per week onsite in Plainsboro, NJ. Development of People Supervisory Ensure that reporting personnel have individual development… more
- BioAgilytix (San Diego, CA)
- …to the patients who need them.Essential ResponsibilitiesServe as Bioanalytical Project Manager (BPM)/Principal Investigator (PI) on a projectMay prepare and submit ... as lead scientist on assay dev projectServe as lead scientist on validation or qualificationPresent data to clientsIndependently write plans and reports for … more
- Genmab (Plainsboro, NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which includes but ... according to applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and… more
- Merck & Co. (Rahway, NJ)
- …14+ years of relevant experience.Experience in late-stage development, including development, validation and/or transfer of methods for API and intermediates in ... flexibility in adapting to change in a fast-paced, dynamic environment.-Passionate people manager who is committed to talent development of their team to capitalize… 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 ... in a matrix management environment with specific experience in development, validation , start-up and continuous improvement of manufacturing facilities, processes or… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive Actions Reviews and ... approves validation documentation Reviews and assesses deviations; includes tracking, follow-up and reporting/trending Reviews manufacturing and support records to… 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 ... minimum eight years of demonstrable work experience in security officer or manager function with strategic / tactical responsibilitiesFive or more years of… 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)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports… more
- Fujifilm (College Station, TX)
- …the hub of innovation, representing a source of pride for the area. The Validation Manager will be responsible for management, scheduling and/or hands on ... one of the 4 Manufacturing Buildings (NCTM, TBF-100, FBF-200, FBF-300). The Validation Manager will be responsible for updating the corresponding manufacturing… more
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