- Insmed Incorporated (Bridgewater, NJ)
- …is aligned with business objectives.As the strategy evolves, prepare alternative development and risk management scenarios, project updates and options and ... processes. This position will be accountable for all necessary strategic planning, risk management , operational execution and communication required for the… more
- Merck & Co. (Durham, NC)
- …drug substance or drug product.GMP experience with qualification of equipment.Experience with Quality Risk Management . Project Management experience in a ... biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …implement modifications to risk assessment plans. Key Responsibilities Follow QRM (Quality Risk Management ) process per ICH Q9, identify the risk , ... required in technical discipline: Engineering, science or similar field. Pharmaceutical/Life Sciences project management professional plus a minimum of 1 year of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …minimum of five (5) years' experience in an engineering or technical discipline Project management experience with emphasis on within IT &/or Manufacturing ... Engineering, Automation, Validation, IT, Manufacturing, Quality Assurance and Quality Control , on project teams to facilitate design,...Automation ie, PAS-X Project Management Professional PMP and/or Disciplined Agile… more
- Merck & Co. (Rahway, NJ)
- …, and closing. Project team development, project team leadership, meeting management , and resource coordination. Risk management planning (ie, risk ... customer, and stakeholder expectations, facilitates cross-functional decision making, and performs risk management . Represents functional areas and GDMS on… more
- Merck & Co. (Austin, TX)
- …to incident, recovery, and post-mortem activity. - Develop expertise in Third Party Risk Management , Supplier Performance Analytics, and Supplier Management ... configuration of SAP Ariba SLP , Supplier analytics and risk management applications such as Aravo and...Management , IT Infrastructure Management , IT Performance Management , IT Procurement, IT Project Implementation, IT… more
- Merck & Co. (Rahway, NJ)
- …(CRMs) and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance ... and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies: pro-actively plans, drives and… more
- Merck & Co. (North Wales, PA)
- …Chemistry, Chemical Engineering or equivalent preferred.Previous experience supporting PQC management and regulatory inspections.Strong project management ... Job DescriptionThe Senior Specialist, Quality Management Systems and Compliance reports to the Director,...thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and… more
- Merck & Co. (North Wales, PA)
- …ready.INSPECTIONS: Responsible for maintaining ongoing inspection readiness for system integration of risk management and central analytics processes as well as ... oral and written communication skills in an international environment.Excellent project management and organizational skills:Strong leadership skills that… more
- Tris Pharma (Monmouth Junction, NJ)
- …and analytical preparationsAuthors Residual Solvent, Elemental Impurity and Nitrosamine risk assessmentsMeets project deadlines and performance standards, as ... Assurance (QA) Research and Development (R&D) Analytical Chemist supports Quality Control (QC) and Analytical R&D (AR&D) activities by initiating appropriate change… more
- Tris Pharma (Monmouth Junction, NJ)
- …building talent across the organization and by applying overall and specific project management and organizational leadership expertise to the clinical ... execution obligations Fosters a culture of quality-by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue… more
- Merck & Co. (Rahway, NJ)
- …in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position ... organizational skills to multi-task.Desire and willingness to learn, contribute and lead. Project Management experience with demonstrated skills.Candidate must be… more
- Merck & Co. (Durham, NC)
- …creating and managing all profit plans and forecasts throughout the year PROJECT MANAGEMENT Responsible for major equipment related projects, including funding, ... divisional or regulatory audits/inspections.Good oral and written communication skillsProject management , including change control and equipment qualification… more
- Merck & Co. (North Wales, PA)
- …for Research & Development projects (data, analyses, tables, graphics, listings)Excellent project management skills; leadership across multiple and complex ... manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level and along the clinical trial process in support of a proactive quality risk management process. Interact with the audit function. The respective Data ... Head of R&D QA. Within assigned GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conduct is completed in compliance and meets Novo Nordisk's business standards Risk management : Assessing and mitigating risks associated with operations, ... within a matrixed environment and with varying professional levels Leads Clinical Ancillary Management project teams to ensure Clinical Ancillary Management … more
- Merck & Co. (Rahway, NJ)
- …the desired outcomes cross functionally, ability to influence decision making, project management skills and results oriented.-Experience working in SAP ... to understand differences and ensure timely resolution.-Maintain strong internal controls over respective Above Market Processes (ie, Intercompany Profit… more
- Merck & Co. (Durham, NC)
- …maintaining accurate documentation of activitiesUndertaking SAP transactions and change control activities including spare part lists and preventative maintenance ... handling unit maintenance, operations, and reliability)Automated systems (eg, Distributed Control System, Programmable Logic Controllers)Maintenance equipment (eg, tools, calibration… more
- Merck & Co. (Rahway, NJ)
- …and novel technologies - through active collaboration with cross functional project teams and external vendors. Designing scientific studies to inform the ... application (NDA)/ worldwide marketing application (WMA) submission documents across the project development lifecycle, as well as responding to agency questions. -… more
- Merck & Co. (Rahway, NJ)
- …print solutions. Additional responsibilities include support of printer configuration, management and security configuration.The incumbent will also be responsible ... in order to set global standards and perform lifecycle management of bar code printers and software systems. The...succeeds in utilizing these capabilities and we minimize our risk of outages that can impact our operations.The engineer… more
