- embecta (Parsippany, NJ)
- …the company's operations, with a focus on financial integrity, operational efficiency, regulatory compliance , and enterprise risk management . As a senior ... thinking. + **Business Acumen & Operational Insight** + Broad understanding of **finance, operations, compliance , and risk management ** , with a history of… 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 ... the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous improvement around… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities in collaboration with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical database (edit checks, CCG ... file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking… 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 ... access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design,… more
- Merck & Co. (Rahway, NJ)
- …Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming Language), Risk Management , R Programming, Science, Scientific Literacy, Trade ... to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data ...of current and future information needs Strong commitment to compliance and ethical standards in data handling… more
- Merck & Co. (Rahway, NJ)
- …and be decisive in an ambiguous environment.Experience and ability to achieve compliance goals through a risk -based approach with a deep understanding ... ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below aspects of the Supplier… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Pharmaceutical Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, Scientific Data Management , ... quantitative systems pharmacology, model-based drug development (MBDD), or scientific data management .- Proven experience leading cross-functional teams to… more
- Merck & Co. (Rahway, NJ)
- …point for the docketing team, attorneys, and staffImmediately reports all risk management -related concerns to Senior LeadershipResponsible for the compilation ... checks are performed and discrepancies resolvedOversee IP docketing system to ensure data integrity, accuracy, and compliance with rules and departmental… 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)
- …Capital Project Management , Capital Projects, Change Management , Cybersecurity Risk Management , Data Analysis, Deviation Management , Equipment ... start-up operations (FLEx) and new capital builds, including automation lifecycle management , data /analytics, and site representation on capital projects.- Some… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Malware Analysis, Management Process, Penetration Testing, People Leadership, Risk Management , Security Information and Event Management ... Model ethical conduct, transparency, and accountability in every action; ensure compliance with cybersecurity and data privacy standards. Demonstrate curiosity,… more
- ValSource, Inc. (Rahway, NJ)
- …21 CFR Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality, ... projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data -Driven Decision Making, ... drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAPAs, change controls and complaints.Perform analysis on quality indicating data and identifying trends.Contribute to maintain investigation compliance ... able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and… more
- Merck & Co. (Rahway, NJ)
- …Communication, Data -Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management , ... strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and capital expenditures (CapEx), ensuring alignment with business objectives, quality, compliance , and cost optimization. The role will work closely with ... goals. The Manager will play a key role in vendor management , contract negotiation, and operational procurement excellence.Key Responsibilities Support and lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an approved cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes ... functional partners.Key Responsibilities Integrate into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and ... while ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend… more
