- Eisai, Inc (NJ)
- …minimize risk .Manages vendor qualification processes and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and ... and execution of outsourcing strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards.… more
- Eisai, Inc (Nutley, NJ)
- …performance and reduce potential risks.Oversees vendor qualification and collaborate with Vendor Risk Assessment teams to ensure vendor strategies comply ... of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. This role is accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …certification program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the ... involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. Establish lessons… more
- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.Support development and gathering of ... quality metrics for Legend's Quality Management Review (QMR).Support management of the Quality Management Review (QMR) program.Support continuous improvement efforts through the monitoring of audit metrics.Assist with the development, maintenance and execution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …close out) including timeline, and budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and extended team to ... trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT),...data and ensure timely study delivery-Lead the CRO and vendor selection process and scope of work in collaboration… more
- Cipla (Central Islip, NY)
- …terms and secure best discounted pricing. Addressing on time response from vendor for closure of deficiencies within desired timelines. Key Interactions Who ... External IPD/R&D - new product development, AVD SAP MDM/AQA - Vendor Selection. MFG/Operation team/other departments: PR-PO, Rate contract, Agreements QA/QC -… more
- Eisai, Inc (Nutley, NJ)
- …solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires deep expertise in privacy law, strong communication and ... who is comfortable working in a fast-paced environment, able to balance legal risk with business needs, communicate complex issues in relatable terms, and embed… more
- Insmed Incorporated (NJ)
- …as appropriate, including timelines, budget, data delivery and reporting, vendor management, GCP, etc.Develops operational strategies for implementation of clinical ... TMF quality standards.Work with outsourcing/procurement management to optimize the vendor governance structure, incorporate performance metrics, and contribute to… more
- Aequor (Thousand Oaks, CA)
- …own medium-to-large improvement projects from problem definition through vendor /technology evaluation, piloting/validation, SOP generation, and handoff into ... and integrate laboratory automation (eg, liquid handlers, tube handlers, etc.); develop vendor assessments and implementation plans. Author, revise and own SOPs and… more
- Formation Bio (New York, NY)
- …Maintain efficient systems and processes that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards. Provide leadership and ... the support and resources they need to succeed. Creating and implementing risk -based quality strategies that identify and address potential quality risks. Managing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …automation strategies through cell therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP ... experience preferred.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.Ability to work independently… more
- Insmed Incorporated (NJ)
- …Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous ... teams; translate protocol design into demand/supply plans, contingency strategies, and risk mitigation across global marketsSupport the development and monitoring of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …potential Brand application.Responsibilities:- Leads all strategic sourcing efforts from vendor assessment, RFP, negotiation, award and contracting with senior ... and conditions for cost, quality, payment terms, timelines and mitigates any risk ; while ensuring all contracts are executed in accordance with company policies.-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …enterprise goals. The Manager will play a key role in vendor management, contract negotiation, and operational procurement excellence.Key Responsibilities Support ... and implement opportunities for cost savings, process improvements, and risk mitigation.Directly support internal audits, regulatory inspections, and procurement-related… more
- Cipla (Hauppauge, NY)
- …the execution of equipment/systems qualifications and validation protocols. Supports vendor 's qualification functions. Assists with developing written procedures for ... Assists with developing validation/qualification deliverables such as Requirements Specifications, Risk Assessments, Traceability Matrices, and validation Summary Reports. Supports… more
- Genmab (NJ)
- …assessments, country and site selection, patient recruitment forecasting, and operational risk analysis.Serve as a senior strategic partner to Development Operations ... Feasibility on function-wide priorities such as resourcing, standards, and vendor strategy.Competencies and Attributes:Education:Minimum BS/BA required; advanced degree preferred.Language:Fluent… more
- Formation Bio (New York, NY)
- …ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they escalate. ... Oversee vendor relationships and governance, holding external partners to high standards of quality, cost control, and on-time deliverables. Serve as the Operations… more
- Insmed Incorporated (San Diego, CA)
- …Provide strategic leadership and decision making on CSV strategy Develop risk -based validation strategies for system implementation and changes following CSV SOPs ... and Work Instructions Coordinate all validation activities with outsourced validation vendor when managing cloud applications. Manage and provide oversight on… more
- Insmed Incorporated (NJ)
- …control, periodic reviews, and audit trail reviews.What You'll Do: Develop risk -based validation strategies for system implementation and changes following CSV SOPs ... and Work Instructions Coordinate all validation activities with outsourced validation vendor when managing cloud applications. Manage and provide oversight on… more
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