- Insmed Incorporated (NJ)
- … risk assessments and develop mitigation strategies CSV Program Oversight : Oversee the CSV team, validation strategy and continuous process improvementEnsure ... We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational risk management plan is in-place and applies a smart- risk taking philosophy-Responsible for the delivery, oversight , performance and management ... around rare diseases and immune disorders. SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended...budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a ... audits.Perform analysis on quality indicating data and identifying trends.Provide oversight for trending of quality compliance metrics.Job duties performed routinely… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global regulatory ... development and submission activities. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions and will act… 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
- Insmed Incorporated (NJ)
- …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 1-2a, ... project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, monitoring oversight of site-level… more
- Merck & Co. (Rahway, NJ)
- …second generation process development and health authority licensure. - You'll lead the charge in transforming our late-stage pipeline into reality bringing ... Deliver robust DS strategies for successful commercialization. Provide technical oversight of cell culture process development, process characterization and… more
- Insmed Incorporated (NJ)
- …and environmental protection for all Insmed locations.Key duties include risk assessment, developing safety policies, managing training programs, and ensuring ... Insmed's Director of Environmental Health & Safety (EH&S), the individual will lead the development, implementation, and management of a company-wide EH&S program… more
- Insmed Incorporated (San Diego, CA)
- …outsourced validation vendor when managing cloud applications. Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation ... Provide strategic leadership and decision making on CSV strategy Develop risk -based validation strategies for system implementation and changes following CSV SOPs… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Global Science & Technology Network leadership team to lead complex, site-to-site technology transfers for Animal Health vaccines across our ... unconstrained supply that supports business growth. You will provide strategic oversight , standardized methodology, and hands-on leadership to transfer teams and… 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
- 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
- Formation Bio (New York, NY)
- …As a tech enabled development organization, there is a substantial component of oversight for the computer systems validation. The implementation of the QA strategy ... with internal and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the effective review and approval of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support to ... The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project...for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved… more
- Merck & Co. (Rahway, NJ)
- …robust DS strategies for successful commercialization. Provide technical oversight of cell culture process development, process characterization and ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… more
- Merck & Co. (Rahway, NJ)
- …seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build ... decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, will be responsible for… more
- Insmed Incorporated (NJ)
- …will include, but not necessarily limited to the following: Develop risk -based validation strategies for system implementation and changes following CSV SOPs ... validation vendor when managing cloud applications. Manage and provide oversight on multiple projects simultaneously. Author CSV Documents (Validation Plans… more
- Merck & Co. (Rahway, NJ)
- …inquiries, and support internal/external auditorsLeadership and development:Provide day-to-day oversight , coaching, and professional development to staffFoster a ... accountability, continuous improvement, and operational excellenceDrive improvement and special projects: Lead /participate in process optimization, system enhancements, and cross-functional initiativesContribute… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status. ... Demonstrated ability and knowledge to define, and lead the implementation of, process/system improvements related to regulatory...for managing projects, processes, or programs with own manager oversight Full knowledge of FDA and Health Canada eCTD… more
