- Genmab (Plainsboro, NJ)
- …policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep ... the implementation of technical rules and standards for privacy compliance in data life cycles and deployment of technologies...oversight of Genmab data processors in accordance with Genmab's risk management framework and data privacy and… more
- Insmed Incorporated (San Diego, CA)
- …the Senior Director will be responsible globally for executing the safety and risk management activities. This individual is responsible for safety surveillance, ... risk management , and risk communication...and Legal. Leads the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance … more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …capability to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead on the ... Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team...manufacturing operations.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to work… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Are you ready to realize your potential? The Position This position will lead a team of Validation Engineers and Validation Technicians, and is responsible for ... independent and maintains up-to-date knowledge of relevant standards and regulatory compliance requirements and independently contributes to the development of the… 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
- Merck & Co. (Rahway, NJ)
- …country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure ... part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving...and Hub data and experience with patient journey and risk stratification is a plusTranslate use cases into implementation… more
- Formation Bio (New York, NY)
- …health authority audits.Responsibilities Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory ... ensure the consistent production of safe, effective, and high-quality pharmaceutical products. Lead internal and external audits to assess compliance with… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and application and other key drivers of enhanced quality.Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical ... globally and with external parties as required.Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi… more
- Novo Nordisk Inc. (Durham, NC)
- …Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with little guidance ... Responsible for the production activities & validation. Ensuring relevant compliance issues are addressed & handled in close collaboration...root-cause analysis tools & techniques a plus Experience with Risk Assessment & Risk Management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality ... the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from...and post-inspection-related activities under the supervision of the IMT Lead . Management Review: Collect the data and information… 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
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... and local site procedures for safety, quality, and regulatory compliance - Understand the big picture, and how activities link...to our Company strategy and business goals- Utilize device risk management tools to build device or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor selection process in collaboration with the study team and outsourcing procurement management . Lead the creation of the CRO scope of work in collaboration ... with Outsourcing Procurement Management . Lead trial feasibility and site identification activities...and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead … more
- Merck & Co. (North Wales, PA)
- …- Individuals in this role should have shown the ability to mentor, coach, and lead teams (direct line management and indirect management of individuals with ... strategies to help with patient analytics (eg, Persistence, Adherence, Risk Stratification, etc.), achieve health objectives, and improve patient...role will be an independent contributor as well as lead a team and, together, will act as the… more
- Tris Pharma (Monmouth Junction, NJ)
- …Leadership team including insights on financial performance, capital allocation, and risk management ; Directs cost monitoring and reporting activities; Drives ... In depth knowledge of corporate financial law, compliant financial reporting and risk management practices Excellent knowledge of data analysis and forecasting… more
- Merck & Co. (Rahway, NJ)
- …as Content Lead for one or more GPV sub-teams (eg, training, risk management , procedure management ):Establish team priorities and allocate resources ... which the Senior Specialist is responsiblePV Statement preparation in compliance with relevant regulations, policies, and proceduresSame/similar designation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAccountable to lead , manage and ensure that all Contract Manufacturing, Testing and Warehousing ... risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and...appropriate way and to ensure continuous improvement in the management of CMO risks. Interacts with DS affiliates and… more
