- Daiichi Sankyo, Inc. (Bernards, NJ)
- …per DSI Internal control - Support the Head Global QA strategy and operations to develop and plan the Global QA communication strategies and manage the ... Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks...that may impact multiple Global organizational units or Global project teams. This position has advanced skills in technology… more
- Merck & Co. (Rahway, NJ)
- …compliance.-Essential Duties and Responsibilities:Program Leadership and Technical Project Management:Provide program leadership in the development, ... validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills and principled verbal and… more
- Merck & Co. (Rahway, NJ)
- …oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will ... guiding product and process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or other supplemental studies to support development of Dx devices under design control process. They will lead identification and selection of Dx assays and ... members of Global Companion Diagnostics, Translational Sciences, Global Clinical Operations , Biostats and Data Management and Clinical Development. Responsibilities… more
- Merck & Co. (Durham, NC)
- …or InstrumentationPreferred 5 years of plant maintenance and familiarity with regulatory requirements in accordance with GMP manufacturing operations Operation, ... and oralEffective maintenance, troubleshooting, and problem-solving skillsWorking knowledge of regulatory requirements in accordance with GMP manufacturing operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Investigation Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR -T Investigation ... productivity, yield, and cost.Implement process improvements within the change control system.Recognize and act on potential compliance issues and opportunities… more
- Merck & Co. (Rahway, NJ)
- …critical thinking. Additional responsibilities include authoring technical reports and regulatory documents, presenting technical data, and project management. ... of connectivity between the functions supporting the pipeline (ie- quality, regulatory , clinical development; chemistry, manufacturing, and control (CMC); supply… more
- Merck & Co. (Rahway, NJ)
- …experience including finance, accounting, analytics, risk management, and special project opportunities.MCAAS Innovation FLDP participants will be placed within the ... allow individuals to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our global business … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,… more
- Merck & Co. (Durham, NC)
- …HVAC, and/or multi-stage refrigeration systems) Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations ... Effective maintenance, troubleshooting, and problem-solving skills Working knowledge of regulatory requirements in accordance with GMP manufacturing operations .… more
- Merck & Co. (Durham, NC)
- …member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, ... coordination leadership and implementation of troubleshooting activities and change control .Initiate and lead collaboration within the Operations , Quality and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Content Management & Production Lead reports directly to the Experience Operations Lead as part of the Customer Experience & Marketing Enablement organization. ... Experience & Marketing Enablement, including Omnichannel Engagement, NextGen, Marketing Operations , Experience Intelligence and Strategic Support & Execution. Outside… more
- Merck & Co. (Durham, NC)
- …for leading a team that supports deviation management, change control , site qualification/validation, equipment qualification, and technical support quality for ... and approve Quality Notifications (QNs)Author, review, and approve SOPsTake on project management opportunities, by leading and participating in process improvement,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This position is responsible for supervising personnel and operations involved in applicable department. This position requires strict adherence to ... documentation associated with the job duties of applicable department Assures operations and practices comply with established procedures and records Assures… more
- Aequor (Thousand Oaks, CA)
- …relationships with CMO Supply Chain Team Executing end-to-end supply chain operations such as order and invoice management, shipment management, warehouse ... the demand/supply planning and inventory management in support of regulatory filing, clinical/commercial supply, and/or product launch and lifecycle management… more
- Merck & Co. (Rahway, NJ)
- …including finance, accounting, analytics, risk management, and special project opportunities.Corporate Audit and Assurance Services (MCAAS) Finance Leadership ... allow individuals to gain knowledge on products, healthcare systems, payors, and regulatory and reputational risks while working intimately with our global business … more
- Merck & Co. (Durham, NC)
- …and future manufacturing requirements, assures its configuration is aligned with regulatory requirements, maximizes business benefits, and aligns it with our ... implementation of the technology, executing implementation, and maintaining ongoing operations . The MES Specialist will have regular direct interaction with… more
- Insmed Incorporated (San Diego, CA)
- …including interpretation of results and reporting that stands up to regulatory inspection.Demonstrate expert knowledge of scale-up principles with respect to viral ... and procedures suitable for inclusion in pre-IND, IND, or equivalent regulatory submission;Must be familiar with BSL-II lab safety requirements;Participate in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ICH and regional guidelines with the goal of right first time approval of regulatory control strategies.Evaluates and implements new regulatory and quality ... Associate Director, Analytical Regulatory Sciences, Systems & Operations in...on the construction, documentation and defense of the analytical control strategies in regulatory submissions preparation and… more
- MBTA (Boston, MA)
- The Deputy Director Operations Control System (OCS) is responsible for overseeing and leading the technical staff managing the MBTA Operations Control ... System (OCS). The Deputy Director Operations Control System (OCS) will report directly to the Director...field team members have received the proper right-of-way training.Establish project goals and monitor progress to ensure the efficient… more
