- 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)
- …protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees the execution of external data -- acceptance, ... diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in... protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … data management strategy across regions and across studies/programs.- Represents Data Management in governance bodies internally and externally with ... identifies and manages risks for the data management function and supports functional risk identification/...CRO governance committee, provides strategic leadership in Data Management related topics and establishes the… more
- Merck & Co. (Rahway, NJ)
- …resultsUnderstanding and experience with business functions, such as Source to Settle, Supplier Management , Risk Management , Facilities Management , Site ... Management , Pharmaceutical Research, Product Management , Requirements Management , Requisition Management , Risk Assessments, Software Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …epidemiological data , and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert ... signal management activities. They will lead the safety signal governance and develop, or update associated policies, charter and procedures, as applicable.On… more
- Insmed Incorporated (NJ)
- …opportunities, and drives enhancements through collaboration, training, and data -driven optimization aligned with Insmed's strategic goals.The Associate Director, ... & Process is responsible for overseeing the quality monitoring, process management , and continuous improvement efforts that support Insmed's patient services… 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 ... managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity...executive management , governance board committees and oversight groups… more
- Cipla (Fall River, MA)
- …a highly visible individual contributor role that reports to the Director of Project Management , R&D, North America. The job duties for this position include but are ... not limited to the following: Responsible for end-to-end project leadership and management (scope, cost and time) deliverables for Cipla projects. Operate as the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … data analytics relating to sourcing initiatives.Strong understanding of risk management processes and experience developing mitigation strategies.Skilled in ... building a high-performing global sourcing organizationAssess and periodically update risk scores for BOM and other high- risk materials.Co-develop… 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 ... aspects of regional and global studies as appropriate, including timelines, budget, data delivery and reporting, vendor management , GCP, etc.Develops operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …platforms) Support system change control, validation, and upgrade activities Governance & Change Management Support Safety/Quality/Training leadership in ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Merck & Co. (Rahway, NJ)
- …units; however, the position will focus on US Quality activities related to governance by the USDA.-- The role will require collaboration with manufacturing sites, ... and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for facility design,… 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 ... of the corporate influencer program by contributing to driving strategy, governance , and collaboration with brand teams to create engaging consumer-focused social… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and quality forums under the Joint Manufacturing Committee in the commercial governance structure. The candidate will also be required to collaboratively work within ... cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA stakeholders and CROs to ensure high ... with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through...managed activities with the goal of achieving the highest data quality standards, full adherence to patient's rights and… more
- Merck & Co. (Millsboro, DE)
- …elevating standards across R&D and commercial manufacturing.Drive continuous improvement and risk -based technical governance at this new lyophilization site.Key ... R&D and commercial manufacturing with strong systems thinking and governance discipline.Practical experience with freeze-dry studies, cycle development and… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountability Ethical, resilient, and committed to excellence Skilled in risk management , team facilitation, and strategic planning Experience in ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… more
- Insmed Incorporated (NJ)
- …expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical manufacturing, analytical method ... partners. The position is critical in shaping quality strategy, managing risk , and supporting regulatory readiness for complex, evolving pipelines.What You'll Do:… more
- Jobleads-US (Boston, MA)
- …with practice groups and administrative departments to improve information workflows and reduce data risk . Compliance and Security o Work closely with the Chief ... of data and records. o Monitor compliance with information governance policies, client outside counsel guidelines, and industry best practices. o Support… more
