- Merck & Co. (Rahway, NJ)
- …CRA (Clinical Research Associate) manager and/or functional vendor and internal management as-needed.Performs Quality control visits as required.Leads local ... and adverse event reporting-requirements internally and externally.The CRM (Clinical Research Manager ) could be responsible for a particular study for several… more
- Aequor (Thousand Oaks, CA)
- …source for Contract interpretation and application during project execution Work with Project Manager and Project Controls Manager to resolve valid ... for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... aspects related to Quality Systems, Finished Product Batch Release, Change Control , Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repositoryCoordination… more
- Insmed Incorporated (Bridgewater, NJ)
- …disciplines by: a) performing the duties of a trusted senior project manager and b) jointly developing project delivery best practices, standard methodology and ... project budget and resource allocation and ensuring adherence to financial controls .Ensures project deliverables meet quality standards and are delivered on… more
- Insmed Incorporated (San Diego, CA)
- …calibration, and safety checks. Oversees and reviews area weekly and monthly Quality Control and maintain QC database. Set up and validate new assays as assigned ... by the manager .ResponsibilitiesManage and direct work responsibilities for team as well...latitude required in the role, and external market and internal value when determining a salary level for potential… more
- Catalent (St. Petersburg, FL)
- …Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control .The QA Product Manager provides customer service, with the highest ... QA Product Manager Position SummaryThe QA Product Manager ...compliance with partnership with Catalent St. Petersburg's customers and internal organizations. This position serves as a representative for… more
- Merck & Co. (North Wales, PA)
- …with and provide oversight/direction to Suppliers and communicate with internal cross-functional teams to share project status and mitigations.Track ... timelines/deliverables and follow up on action items (Supplier and internal teams/scientists).Maintain key study information in applicable system(s) and manage… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business for guidance ... validation. Support computer system audits for review of SDLC and data integrity controls . Review CAPA and verification of CAPAs of system audits. Support health… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …accordance with established policies and procedures, develop proposals, implement project controls , facilitate and manage effective internal and external client ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure all systems are operating well as designed. Ensures compliance with internal controls and accounting policies. Optimizes Financial Disbursement technology ... through system upgrades and other proven automation practices to build efficiencies and stay ahead of the latest technological trends. Works closely with Finance, Procurement, Legal, IT and other departments, as required. Increased focus will be placed on… more
- BioAgilytix (Durham, NC)
- …a variety of project support through all phases of our client services. As a Project Manager I, you will be the glue connecting our internal functions to the ... you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPartner with internal and external stakeholders to define project timelines, ensure projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …procedures and/or systems to improve organizational efficiencies and cost controls .Communication and Relationship Management - Leads contract related communication ... with vendors. Respond to questions from internal staff regarding status of contracts. Interacts with vendors...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- BioAgilytix (Durham, NC)
- …post-market product changes and decision on appropriate mechanism for change control (eg internal documentation, notification of change, supplemental ... life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing team.Support… more
- Eisai, Inc (Nutley, NJ)
- …functions and compliance controls .Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate potential unlawful ... Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information Systems Auditor (CISA), or other similar credentials.Strong… 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 ... auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record... to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues Performs… more
- Catalent (St. Petersburg, FL)
- …aspects related to Quality Systems, Finished Product Batch Release, and Change Control .II. Basic Function: This position is responsible for managing and documenting ... Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The Senior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This position is responsible for providing support to the Senior Manager and Director of Institutional Contracts by leading the team through the ... for all non-retail channels consistent with the agreement terms, corporate controls , and Sarbanes-Oxley regulations. Relationships Reports directly to the Senior … more
