- Merck & Co. (Durham, NC)
- …critical role in the network of life-saving medicines and vaccines. - The Associate Director , Quality Systems and Compliance provides expertise in the ... weekend support during critical processing and manufacturing. FUNCTIONAL EXPERTISE: The Associate Director , Quality Systems and Compliance will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …remediations and risk management in close collaboration with the organization's quality management system , to assure robust knowledge transfer and continuous ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports...Plan together with the supported CSPV teams, including the quality risk assessments and inspection readiness components… more
- Merck & Co. (Durham, NC)
- …technical guidance/support for key review and approval of automation incidents, Quality Notifications (QNs), system commissioning and qualification, change ... Job DescriptionPosition Description Associate Director , Automation The Associate Director Manufacturing Automation is responsible for managing the team in… more
- Merck & Co. (North Wales, PA)
- …touchpoints.- We assist our Field Sale Team, healthcare providers, and healthcare systems to help them meet their contractual and vaccine ordering goals.-The ... Director for our Company's Vaccines National Accounts has overall...Order Management Center, Business Service Center) to ensure a quality and value driven customer experienceCollaborates closely with other… more
- Merck & Co. (Rahway, NJ)
- …execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. ... The Equipment Development and Facility Engineering (EDFE) Leader position will report to the Director , Engineering and will be a member of the EF Team at the Rahway… more
- Merck & Co. (Rahway, NJ)
- …global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Eisai, Inc (Nutley, NJ)
- …governance and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information ... JSOX compliance.Maintain accurate compliance documentation and advise control owners.Assess risk , evidence adequacy, and remediate findings.Evaluate new system … more
- Merck & Co. (Rahway, NJ)
- …Software Development, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, Systems Integration, TestingPreferred Skills:Design, Global ... Areas of expertise should include but not limited to--PP/PI, EHS, Production Execution, Quality and Logistics. This role also provides close support to the Process… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , PMO People & Process LeadGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our ... their parts of the Research & Development division.The Associate Director , PMO People & Process Lead, is a unique...of how our clients navigate business processes and enabling systems to deliver their job responsibilities. In this role,… more
- Merck & Co. (Rahway, NJ)
- …in the Design Authority.- They will ensure the smooth operation of our SAP systems with a mindset towards continuous improvement.- Their expertise in SAP System ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director - Tax We are seeking an experienced tax professional to join our team as an Associate Director of Tax ... Director of Tax Operations will report to the Director of Tax Operations and will work closely with...related to tax operations and ensure the delivery of high- quality work products to ensure our company remains in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life Cycle ... and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance. Proactively track, monitor and report trial risks,… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... with CMC and Regulatory in aspects of control strategy and filings, Quality , and our partners in the commercialization and manufacturing division.This challenging… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to operationalize the feasibility approaches.Partner with internal and external data/ systems centers of excellence to identify, monitor, analyze and appropriately ... act on key quality and performance indicators for process oversight/adherence, and measure...and patient voice related portfolio of platforms, tools and systems .Design, lead and implement the GCO delivery framework for… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas Infrastructure Director , your role involves collaborating with other Eisai regions and global Enterprise ... leadership to managed services vendors to drive performance improvement, quality , and cost optimization.Drives a culture of continuous improvement that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quantitative and qualitative means. Candidate will define Key Performance Indicators, Key Quality Indicators, Key Risk Indicators, and other targeted operational ... or More Years Minimum 5 years' experience with one or more clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. required4 or More… 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 the study ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the...of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system . Ensure ... Management will provide strategic direction and leadership for the investigations management system . Working closely with the Quality Senior Manager, this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance, Medical Affairs, Translational ... business users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to… more
