- Merck & Co. (Rahway, NJ)
- Job Description Job Description: We are looking for a manager to lead and manage the validation and testing activities for our platform products. This role will ... delivery of high-quality software solutions.Responsibilities: Develop and implement an effective validation and testing strategy for the platform team, in line with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance of validated...capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Novo Nordisk Inc. (Durham, NC)
- …Relationships Manager . Essential Functions Ensure accuracy & compliance of validation & equipment records Responsible for validation of QC equipment ... help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed … more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Catalent (St. Petersburg, FL)
- …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support ... Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... analysis of human biomarker datasets to inform biomarker identification and validation , clinical development and business strategies. As the study statistician, this… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- Novo Nordisk Inc. (Durham, NC)
- …support is on site as needed during production activities Coordinate all validation /transfer activities involving MDev support Lead team in successful execution of ... of cGMP's is required Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility,… more
- Tris Pharma (Monmouth Junction, NJ)
- Sr Project Manager , Operations for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead + manage proj plans detailing milestones, bdgt, resources, timing ... + roles + responsibilities for prgms incl scale-up activities, process validation , post- validation changes + comm w/ FDA. Provide tech spt to manufacturing +… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. 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 (Austin, TX)
- …for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and ... contracting negotiations and execution. is searching for a Capital Projects Sourcing Manager , who will be responsible for helping execute the sourcing processes… more
- Aequor (Libertyville, IL)
- …all layers of IT infrastructureMust have GMP and computer systems validation experience in pharmaceutical manufacturing5&plus years of end-to-end project management ... across IT infrastructure projects, Data center, manufacturing automation, Cyber security, IT software development, COTS, SaaS application implementationExpert and Hands-on experience in using Microsoft project professional, planned vs. actual tracking,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the unitized budget against the needs, conducts rigorous negotiation of terms with validation of rates from service providers. Making sure the payment schedules are ... colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering ... to identify roles and responsibilities Work closely with Engineering, Automation, Validation , IT, Manufacturing, Quality Assurance and Quality Control, on project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...protocol driven activities such as tech transfer and process validation Provides guidance on industry best practices, and quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programming is a member of the Biostatistics and Data Management ... programming tasks required to support Data Management and Biostatistics, as necessary.Perform validation and QC/QA of CDISC, SDTM domain output in accordance with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …transfer traceability from Primary Standards to Laboratory Working StandardsSupport validation and production engineers in development of metrological specifications ... for new equipmentDevelop control charts and statistical process controls for calibration standards and resultsAssist in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all… 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 ... projects to support the regulatory department as assigned.Provide support in software validation and migration activities relating to new or existing systems in… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
