- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical monitoring- For studies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and due diligence activities for assigned product(s), as neededActs as audit /inspection Subject Matter Expert (SME) for safety surveillance and risk management ... for assigned product(s), through inspection readiness preparation, and may serve as the primary or back-up SME, and may collaborate with team on CAPAs, including CAPA responses and approvals Project Management:Collaborates with the PSL(s) to proactively plan… more
- SYSCO (Houston, TX)
- …direct Food Safety & Quality Assurance (FSQA) support/evaluation programs and inspection/ audit procedures to ensure compliance of products and processes to corporate ... and Traceability Programs including Mock Recalls Direct Independent FSQA Audit Program - SQF Audits Assist when necessary for...sensory analysis to identify color, clarity. Warehouse and plant audit require close and distance vision to judge GMPs;… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …to ensure attainment of strategic account and NNI profitability goals Review and audit expense reports Market access planning: Assist in providing input into the ... development of related incentive programs Attend industry meetings and develop relationships with industry associations for within Commercial, Medicaid and Medicare channels Create an effective network within area Market Access, including associations,… more
- Merck & Co. (Rahway, NJ)
- …operations to achieve those objectives. -Under the guidance of the Regional Director , Clinical Quality Management (RCQM), and in collaboration with the Clinical ... Research Director (s), the Sr CCQM Lead establishes and/or - local...the preparation / ongoing / follow-up phase of an audit or inspection.In cooperation with local CCQM, local country… more
- Catalent (St. Petersburg, FL)
- …and oversight. The Quality Auditor will be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed ... performing the audits assigned and to develop a planned audit schedule to maximize audits conducted during one trip...site and Suppliers to finalize to allow Supplier Quality Director approval Act as a liaison between suppliers and… more
- SYSCO (Fremont, CA)
- …plans for audit non-conformance(s). Reviews results with Field Food Safety Director . Acts as the site's primary contact during Food Safety regulatory authority ... Safety Program Manager) reports directly to a GSC Field Director , Food Safety and has dotted line reporting to...by BRC, independent third parties, customers, and Sysco's internal audit process, analyze results, determine root cause, and gather… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure...Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.Conduct and/or oversee the CRO oversight… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. Responsibilities:Study Planning ... of the Delivery Lead. Coordinate and liaise with Daiichi Sankyo QA on audit activitiesProvide oversight of the transmittal of trial and site level documents to… more
- Merck & Co. (Rahway, NJ)
- …CRM (Clinical Research Manager), TA Head and CRD (Clinical Research Director ) as needed.-Works in partnership with GCTO (Global Clinical Trial Operations) ... eTMF and various other-systems as appropriate and per timelines.Supports audit /inspection activities as needed.Performs co-monitoring where appropriate.Extent of Travel:Ability… more
