- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … risk management plan is in-place and applies a smart- risk taking philosophy-Responsible for the delivery, oversight , performance and management ... budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and...trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT),… more
- Formation Bio (New York, NY)
- …technology and AI platforms to enhance efficiency and scalability.ResponsibilitiesProject Management Oversight Provide strategic and tactical guidance for ... with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter ... signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for ... and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The role also… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manufacturing Execution Systems Lead and will be responsible for providing project management support to the development and administration of EBR and digital ... CMC, and IT. This individual will be responsible for management and delivery of the project plans for electronic...for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved… more
- Insmed Incorporated (NJ)
- … systems, including documentation, standard operating procedures (SOPs), risk assessments, incident investigation protocols, reporting and emergency response ... and environmental protection for all Insmed locations.Key duties include risk assessment, developing safety policies, managing training programs, and ensuring… more
- Insmed Incorporated (NJ)
- …through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning.Monitors study metrics to ensure quality ... Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV clinical trials, with a key focus on Phase… more
- Insmed Incorporated (NJ)
- …to improve processes and set direction in related areas such as compliance, CRO management , risk management , etc.Ability to prioritize and manage multiple ... to Clinical Operations staff and to project teams for vendor evaluation, selection, management and quality-based oversight .Responsible for the management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for… more
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with region and functional leaders. The leader will have oversight of the building and scaling omnichannel engagement capabilities, the development ... roadmapLead GOMA Digital initiatives including the strategic development and oversight of Global Medical Omnichannel capabilities in collaboration with functions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
- Insmed Incorporated (San Diego, CA)
- …and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews. \tOnsite at… more
- Insmed Incorporated (NJ)
- …expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical manufacturing, analytical method ... Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from toxicology through… more
- Insmed Incorporated (NJ)
- …guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (eg SDLC, IT Change Control) ... and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews.What You'll… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and ... and all applicable regulations.Schedule: Sun-Wed 1st ShiftKey Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing… more
- Insmed Incorporated (NJ)
- …Provide strategic leadership and decision making on CSV strategy using Insmed's risk -based approach. Provide oversight and manage multiple projects at the ... and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for Medical ... Team. Relationship Reports directly to Head of PV Case Management . This role involves the oversight of...PV Case Management . This role involves the oversight of case handling activities across the locations. Collaborate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur in the ... Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting… more
