- Legend Biotech USA, Inc. (Raritan, NJ)
- …that fit the site's needs. The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project delivery.Leads ... and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project...the project .Develops options and solutions to complex project risk problems, providing guidance to leadership… more
- Formation Bio (New York, NY)
- …of quality, cost control , and on-time deliverables. Serve as the Operations Lead for clinical assets and associated studies. Step in as the Clinical Project ... to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the… more
- ValSource, Inc. (Rahway, NJ)
- …ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a ... ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of… more
- Merck & Co. (Rahway, NJ)
- …device product development, such as manufacturing process development and validation, design control , risk management, material and molding, design validation to ... their interdependencies with design verification, including but not limited to, design controls , risk management, materials & molding, process development and… more
- Merck & Co. (Rahway, NJ)
- …Machinery, Automation Engineering, Automation Solutions, Biopharmaceutical Industry, Capital Project Management, Capital Projects, Change Management, Cybersecurity ... integrity, cybersecurity, and lifecycle best practices (commissioning, qualification, change control , obsolescence, periodic reviews)Provide end-to-end operations support for sterile… more
- Merck & Co. (Rahway, NJ)
- …Services primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityUnder ... both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Insmed Incorporated (NJ)
- …This includes shaping policies, guiding training efforts, and building operational controls across project development, construction, commissioning, research and ... and environmental protection for all Insmed locations.Key duties include risk assessment, developing safety policies, managing training programs, and ensuring… more
- Syner-G BioPharma Group (Boston, MA)
- …Travel to client sites will be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and ... or systems for compliance with manufacturing requirements and facility fit. Lead start-up activities, including commissioning and qualification of facilities,… more
- Merck & Co. (Rahway, NJ)
- …MS Office Suite (Outlook, Word, Excel and SharePoint) and Adobe Acrobat ProStrong project management skills, including the ability to lead and oversee complex ... point for the docketing team, attorneys, and staffImmediately reports all risk management-related concerns to Senior LeadershipResponsible for the compilation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal ... best practices, foster a culture of continuous improvement in benefit- risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make informed… more
- Insmed Incorporated (San Diego, CA)
- …Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team ... strategic leadership and decision making on CSV strategy Develop risk -based validation strategies for system implementation and changes following...etc. This role will participate in on site Change Control CAB meetings as the CSV lead .… more
- Insmed Incorporated (NJ)
- …specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical/Manufacturing systems. Project lead experience preferred.Strong experience in Clinical Study ... management and remain in a validated state (eg SDLC, IT Change Control ) per associated SOPs, regulatory and security requirements. \tEnsure compliance and… more
- Cipla (Fall River, MA)
- …is responsible for the creation and revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role ... leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends… more
- Merck & Co. (NC)
- … Project management Experience involving utility system generation, distribution and control are preferred. Lead in the identification and implementation of ... able to organize and manage multiple projects that span different timelines Risk -based decision-making skills without knowledge of all the inputs Strong Microsoft… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical ... monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.Conceptualize, plan, and execute… more
- Novo Nordisk Inc. (Boulder, CO)
- …will manage CMO's to ensure the continuous supply of product and apply risk mitigation strategies, as well as perform formulation studies in a laboratory setting ... as needed. This position will lead a team of Drug Product Managers and manage...Work effectively across all departments, such as Quality Assurance/ Control , Chemical Development, Program Management, Regulatory, Analytical Development, Materials… more
- Genscript USA Inc. (Piscataway, NJ)
- …and project teams. Support permit applications and regulatory reporting. Lead site inspections, audits, and emergency drills. Serve as a liaison with ... federal regulations. The ideal candidate will have strong experience in construction project support, including providing EHS input during early design and planning… more
- Merck & Co. (Rahway, NJ)
- …and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include ... and partners in commercialization and manufacturing in aspects of quality control , compliance, and strategic partnering. Primary Responsibilities: Reports to the… more
