- 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
- 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
- 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. (Rahway, NJ)
- Job DescriptionWith support of Sr CRA (Clinical Research Associate ) and/or CRA Manager, acts as primary site contact and site manager-throughout all phases of a ... 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
- 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)
- …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
- 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
- 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
