- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has advanced skills in continuous improvement, project management , change management , and risk management . Responsibilities Leadership, Direction, and ... around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data...work.- Proactively identifies and manages risks for the data management function and supports functional risk identification/… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to developvalue-added ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...proficiency in ISO 13485, ISO 14971, and other relevant quality management systems.Qualifications:EducationRequired Technical BS degree or… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Merck & Co. (Rahway, NJ)
- …Project Strategy, Regulatory Compliance, Regulatory Requirements, Resource Stewardship, Results-Oriented, Risk Management {+ 5 more}Preferred Skills: Current ... Job DescriptionThe Director , Master Data Management (MDM) will...Team Leadership, Cross-Functional Teamwork, Data Analysis, Data Governance, Data Management Platform (DMP), Data Quality Control, Decision… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies, device risk management , and design verification testing to develop value-added ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in mechanical engineering,… more
- Cipla (Central Islip, NY)
- …manner to ensure avoidance of all actual and potential conflicts of interest Risk management Minimize impact of supplier shortages by proactively identifying and ... Job Title: Director - Procurement, Cipla North America Reports to:...to identify opportunities for cost savings, process improvements, and risk mitigation. Develop, manage and monitor RFQ (Request for… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social… more
- Novo Nordisk Inc. (Boulder, CO)
- …to our patients Work effectively across all departments, such as Quality Assurance/ Control, Chemical Development, Program Management , Regulatory, Analytical ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Merck & Co. (Rahway, NJ)
- …The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.Primary Responsibilities: ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development… more
- Insmed Incorporated (NJ)
- …experience.Proven expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical ... internal teams and external partners. The position is critical in shaping quality strategy, managing risk , and supporting regulatory readiness for complex,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter ... a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the… more
- Insmed Incorporated (NJ)
- …impact public company reporting and internal controls.While Compliance maintains broadly Enterprise Risk Management (ERM), Internal Audit will perform a critical ... of SOX requirements, internal control framework (COSO), GAAP and risk management methodologies.Excellent analytical, problem-solving and critical thinking… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial ... Sr Director , Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management...of the Quality Manual into an annual Quality Plan, including quality risk … more
- Merck & Co. (Durham, NC)
- …tasks.Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.Exhibited leadership qualities such as ... Equipment, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management , Root Cause Analysis (RCA), Technical… more
- Merck & Co. (Rahway, NJ)
- …blisters) meet safety, efficacy, quality , and robust supply standards. Drive proactive risk management activities, including risk assessment, risk ... and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement strategies ... rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and...will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval ... development and implementation in coordination with different regions that incorporates risk identification and mitigation for the post approval change programs and… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... regulatory representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as… more
