- Eisai, Inc (Exton, PA)
- …Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the ... preparation of CMC regulatory submissions that meet global regulatory requirements,...and variations globally; annual reports, product renewals, notifications and change supplements.Tracks Module 3 leaf changes made as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …therapeutic areas. Finally, this position has moderate skills in continuous improvement, project management , change management , and risk management . ... and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management which includes taxonomy, indexing, cataloging, archiving, metadata tagging, content management systems, etc. in Adobe Experience Manager (AEM) DAM. ... to experiment with us? The Position As an AEM DAM (Digital Asset Management ) Librarian, your primary responsibility will be managing internal company assets and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … management skills Anticipates problems and roadblocks to avoid crisis management Communication, change management , influencing, and networking skills ... organization in the planning, submission, review and approval, distribution and lifecycle management of promotional marketing materials. The Manager will oversee… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Insmed Incorporated (San Diego, CA)
- …will join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the ... budget for drug product shipments.Own and support stability and sample management -related Deviations, CAPAs, and Change Controls. Drive related… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change . Are you ready to make a difference? The Position The primary… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …of Quality and Compliance GxP processes including audits, regulatory intelligence, regulatory inspections, change management , and quality risk ... Develop and implement IS governance policies and procedures to ensure effective IS management and compliance. Change Management : Establish and manage … more
- Aequor (Thousand Oaks, CA)
- …Demonstrated experience in a continuous improvement role applying tools, methodologies and change management (ie Lean, Six Sigma) Demonstrated ability to ... top of the resume is seeking a Supply Chain Manager to be a part of our External Planning...and SAP, to optimize the demand/supply planning and inventory management in support of regulatory filing, clinical/commercial… more
- Aequor (Austin, TX)
- … and Project Controls Manager to resolve valid contractor disputes, claims and/or change orders Experience in construction within the Pharma industry is a plus. ... Remote - EST or CST time zone preferred. MANAGER IS OPENING CAP, PLEASE SUB AT MARKET RATE! CANDIDATES MUST COMPLETE THE PRESCREENING QUESTIONS FOR REVIEW ON RESUME:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... good day-to-day management of data at Daiichi Sankyo including: the stewardship...complex points to a variety of stakeholders and drive change through persuasion but not organizational power required- 4… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role will streamline business requirements, evaluate, and prioritize project and change request timelines, and ensures seamless integration with existing and ... upcoming internal and external systems.Responsibilities- Management of HCP Engagement Systems- Oversee the development and maintenance of HCP engagement systems to… more
- Eisai, Inc (NJ)
- …provider evaluation & selection, contract & budget negotiation, performance monitoring, change orders, and contract closeout. Drives the contracting process between ... familiarization. Resolves complex issues related to contract negotiation and management . Collaborates with study teams, legal, finance, clinical planning,… more
- Merck & Co. (Durham, NC)
- …Supports the end-to-end product Value Stream Map driving production improvements, inventory management , cost reductions, and standard work at the shop floor level. ... Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required. Author… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … regulatory compliance and technical feasibility of proposed changes.Serve as project manager for the change process and provide coordination to ensure timely ... ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… more
- Merck & Co. (Durham, NC)
- …pharmaceutical vaccine manufacturing environment. Experience in lean/six sigma and change management methodologies. Experience with MRP/ERP systems such ... diverse audience with varying business acumen. Demonstrated technical expertise during regulatory inspections and audits. Demonstrated project management and… more
- Merck & Co. (Durham, NC)
- …Technical, is responsible for leading a team that supports deviation management , change control, site qualification/validation, equipment qualification, and ... and / or customer needs to identify solutionsBUSINESS EXPERTISE:Applies management skills to align staff activities with department objectivesFUNCTIONAL… more
- Merck & Co. (Durham, NC)
- …or finished pharmaceutical environmentFamiliarity with cGMPs and vaccine regulatory requirements.Mechanical functionality and reliability knowledge (asset ... guided by policies, procedures and business plan; receives guidance from manager .Provides planning and scheduling guidance to mechanics and technicians for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigations (QI's). He/she supports CAPAs (Corrective and Preventive Actions) and CCs ( Change Controls) within quality management systems. You will also write ... work instructions that are part of the QMS (Quality Management System).You combine the knowledge of the employees in...of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can… more
