- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation,...support for GCO process improvement activities, projects, inspections and/or audit findings resulting in the need for either a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that fall under the responsibility of the R&D Procurement group. The Associate coordinates with R&D Procurement team members, Purchasing, Legal, Finance, vendors and ... need for change request; manage interactions with Vendor, finalize execute amendment.- Audit Ready/Inspection Prep: As per the audit requirement and processes,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director, SD&PM Third Party Risk Systems & Governance Supplier Development & Performance Management (SD&PM) ... Risk Reporting as requiredEngages with the Enterprise Strategy Office, Corporate Audit and Assurance Services (MCAAS), and various Divisions and functional areas… more
- Merck & Co. (Durham, NC)
- …shift P1 position on the 2/2/3 schedule. The Shop Floor Quality Assurance Associate is responsible for all Quality related functions that directly support Durham ... and embracing an empowered team culture.-The Shop Floor Quality Assurance Associate is responsible/accountable for Quality Assurance activities that support VMF,… more
- Merck & Co. (Durham, NC)
- …with our core principle of Safety First and Quality Always.The Associate Director, Engineering/Maintenance will support a new drug substance manufacturing ... unit operations and associated clean utilities and process equipment.- The Associate Director will manage tactical and strategic process, equipment, and… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders… more
- Aequor (Thousand Oaks, CA)
- …experience in Quality Management Software systems (eg TrackWise, EDMQ, etc) Preferred Requirements Experience in audit / inspection support Technical writing skills ... EW will just need to make sure they are completing the 8 hours daily with a structured schedule** **This is a very GMP compliance driven role and environment. We need a candidate who will be able to read the SOP's and follow them in a very detail oriented… more
- Novo Nordisk Inc. (WA)
- …retention targets Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external ... stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA) Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners Demonstrates technical proficiency within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analytical approaches (eg, identification of outliers to focus monitoring/ audit activities).Responsibilities Compliance Monitoring Responsible for activities related ... to developing, conducting, and reporting the Compliance Monitoring Plan (eg, utilizing monitoring tools/reports, field monitoring and analytics).Annually evaluate and revise the CM plan as necessary.Identify areas of potential non-compliance and assist in the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Head RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality ... GDP requirements, risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned,… more
- Merck & Co. (Rahway, NJ)
- …-This includes line management of Country Clinical Quality Managers (CCQMs) and Associate Country Clinical Quality Managers (ACCQMs) as well as talent development in ... activities during the preparation / ongoing / follow-up phase of an audit or inspection.In cooperation with local CCQM, local country operations and/or headquarters,… 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. Responsibilities:Study ... 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. (North Wales, PA)
- …support by the Operations Team.-The Director position will report to the Associate Vice President, ECO Operations & Innovative Solutions and will be responsible ... manage system translationsManage and ensure appropriate and timely preparation of ECO Audit Committee Report submissions; lead efforts to evolve report content and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides a seamless user experience for customers. Relationships Reports to the Associate Director of Content Management; Provides direct support to the Digital ... and implementing browser and device support criteria across digital content Audit and evaluate existing content and functionality Establish and enforce coding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may ... team lead. Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.Conduct and/or oversee the CRO oversight monitoring visits (CROOM… more
- Robert Half (Philadelphia, PA)
- …REQUISITION Philadelphia Internal Audit & Financial Advisory Technology Audit Associate Director LOCATION PHILADELPHIA ADDITIONAL LOCATION(S) JOB DESCRIPTION ... firm . Where We Need You: Protiviti is looking for a Technology Audit & Advisory Associate Director to join our growing team. What You Can Expect: As an… more
- KPMG (Los Angeles, CA)
- **Business Title:** Audit Associate | Los Angeles Winter 2025 **Requisition Number:** 113075 - 8 **Function:** Audit **Area of Interest:** Campus **State:** ... about your future as we are, join our team. KPMG is currently seeking an Audit Associate to join our Audit Services team. Responsibilities: + Work as part of… more
- KPMG (Baltimore, MD)
- **Business Title:** Audit Associate , Federal Audit (TS/SCI required) **Requisition Number:** 112403 - 42 **Function:** Audit **Area of Interest:** ... future as we are, join our team. KPMG is currently seeking an Audit Associate to join our Federal Audit (https:// audit .kpmg.us/) practice.… more
- Fifth Third Bank, NA (Cincinnati, OH)
- …oversight and monitoring functions of management and support functions. The Senior Audit Associate conducts end-to-end business process audits for various ... and objectivity in all aspects of position. #LI-BP1 Senior IT Audit Associate LOCATION -- Cincinnati, Ohio 45202 Fifth Third Bank, National Association… more
