- Merck & Co. (Rahway, NJ)
- …and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and ... engineering design, engineering analysis and testing, medical device design controls , risk management, test method/fixture development, design verification… more
- 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
- 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)
- …- Principal Responsibilities Lead /Support continuous improvement initiatives for design control and risk management processes Identify and eliminate process ... responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This… 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
- 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
- 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
- Aequor (Charlotte, NC)
- …prototypes, perform mechanical testing, and interpret performance data. Working knowledge of design controls , risk management, ISO 14971, ISO 13485, and 21 CFR ... and contributing throughout the full product lifecycle.Key ResponsibilitiesParticipate in or lead the design and development of complex steerable catheters including… 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
- Unknown (New York, NY)
- …particularly in the context of risk management. The role requires the ability to lead and mentor a team of project management professionals, as well as to ... Head of Enterprise Risk Project Management About the Company...Head of Enterprise Risk Project Management About the Company Prominent financial institution...identify and implement controls and mitigations for risks throughout the … 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
- 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
- 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)
- …management and remain in a validated state (eg SDLC, IT Change Control ) per associated SOPs, regulatory and security requirements. \tEnsure compliance and ... efficiency of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews.What You'll Do: Develop … 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
- Aequor (Thousand Oaks, CA)
- …banks for cell-based potency assay methods in Process Development (PD) and Quality Control (QC), with a primary focus on adherent mammalian cell lines. Support ... focus on closed-system multi-layer vessels (HYPERStack®) for adherent cell lines. Lead process development and automation projects that increase throughput, reduce… 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
- 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
- TRC Talent Solutions (Dalton, GA)
- …with our company and take on future leadership opportunities. Key Responsibilities Lead and coordinate all project activities across design, construction, and ... TRC is seeking a talented Project Manager for one of our Data Center...data center construction projects, ensuring that cost, schedule, document control , and quality standards are met. This role requires… more
- Brinks (Coppell, TX)
- …coordination (eg, product launches, platform migrations, infrastructure programs). Manage risk , dependency, and change control processes across initiatives. ... Team Development Lead and develop a team of globally dispersed project and program managers supporting the product organization. Build a culture of… more
