- Legend Biotech USA, Inc. (Raritan, NJ)
- …projects.Support the enhancement and Global harmonization of the supplier qualification program , including management of the electronic systems for this ... Management Review (QMR).Support management of the Quality Management Review (QMR) program .Support continuous improvement efforts through the monitoring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to support global process validation activities in support of the commercial Carvykti program both within Legend but also externally with our program partner ... partners to track changes to our material/ raw material program and develop best practices for evaluation of changes...same and their impact on the Carvykti product. Stakeholder management is required to drive and implement documentation template… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation ... across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to realize your potential? The Position The Director of Alternative Models Program Management is responsible for ensuring the timely execution of ... By driving the collaboration among teams and key stakeholders, the Director of Program Management oversees the coordination and execution necessary to design,… 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 ... end-to-end processes and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams.Ensure consistent and proactive representation of Quality at all stages of the program management process.May Interact with management at all levels ... access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems and processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal systems and ... for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable for the area...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management , Regulatory Compliance, Risk Management , Sourcing ... and the operational/executional arms within the business.- - The Program Clinical Supplies Project Manager ( Program CSPM)...(ie Bulk Drug Product). Oversees all bulk drug supply management and ensures proper allocation of drug product as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …can clearly convey the status of security and related issues surrounding enterprise risk management decisions to all levels of the organization including ... US Ops position has responsibility for the development, implementation and management of security policies, standards, evaluations, roles and corporate awareness.… 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
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to developvalue-added ... Development and Technology Organization. Thisposition is responsible for providing strategic program leadership, technical expertise, and project management in… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Home Depot (Bridgewater, NJ)
- …available from the enterprise, including Commercial Credit options, Volume Pricing Program , delivery, will call pickup, and website ordering. Establish effective ... with current organization through individual targets/quotas. + 10% - Customer Relationship Management - Utilize Salesforce to plan future sales call activity, manage… 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 ... the Medical Review Team. Relationship Reports directly to Head of PV Case Management . This role involves the oversight of case handling activities across the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …authority and trust Serve as the expert on social media channel performance, risk management , competitive analysis, and emerging best practices to inform ... will also support the development and execution of the corporate influencer program by contributing to driving strategy, governance, and collaboration with brand… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization ... for biologics pipeline programs. Strong capability in managing evolving timelines, program risks and mitigation strategies. In-depth knowledge in upstream cell… more
- Formation Bio (New York, NY)
- …you will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the ... including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk... Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a… more
- Merck & Co. (Rahway, NJ)
- …and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design, ... and ensure team and company adherence to these documents.Develop a risk -based approach to prioritize USDA compliance requirements for our manufacturing… more
- NorthMark Strategies (New York, NY)
- …This role will support the development and execution of best-in-class insurance and risk management strategies across the organization, with a focus on Owner ... insurance brokers, carriers, captive managers, and third-party administrators to ensure effective program management . Assist with claims management , loss… more
