- 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
- 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
- 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
- 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
