- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... Biostatistics and Data Management Data Operations team and serves...review of user access and audit trail reconciliation, impact analysis and documentation of identified access discrepancies per study… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … Manager Facilities, Engineering, and Metrology Essential Functions Engineering Data can include engineering models, drawings, Vendor Data , ... methods and solutions needed to support the efficient collection, storage, transfer, manipulation, analysis and reporting of engineering data as well as the need… more
- Tris Pharma (Monmouth Junction, NJ)
- …laboratory (OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... and indirect compliance, handling state tax audits and notices, evaluating state tax risk , and ensuring realization of state credits and incentives for all Novo… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …CFR Part 11 in a manufacturing settingDemonstrated application of FMEA, Risk Analysis , Validation principles, guidelines, and industry best practiceDemonstrated ... parameters and provide technical leadership for deviation investigations Analyze data to provide recommendations for improvements in the manufacturing process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to government reporting obligations, such as Aggregate Spend and Risk Evaluation and Mitigation Strategy (REMS) including the management and oversight ... processes Additional focus to include submission of all Transparency data to the CMS portal in a timely and...systems and technology used to facilitate the collecting, aggregation, analysis , and reporting of information required High standard of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …functions, to meet unified business objectives.As required, run reports and conduct data analysis to support monitoring of key performance indicators; support ... treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in...the preparation of compliance data for the monthly CRB & quarterly QSMR presentations.Fulfills… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for overseeing the health of the manufacturing processes. This starts with proper risk analysis in manufacturing design, then goes into addressing risk ... participate in Internal Audits as directed by the Quality Manager . In addition, the Quality Engineer will lead continuous...and other regulatory agency audits. Serve as an Internal Auditor. Data Management- perform statistical data analysis… more
- Merck & Co. (Rahway, NJ)
- …scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. The incumbent ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sourcing efforts through to final contract, including project management, supply analysis , supplier identification, risk mitigation, sourcing execution, high ... and methodologies are understood and utilized. Serve as the lead "relationship manager " to proactively deliver strategic sourcing insights, optimal value and best… more
