- Novo Nordisk Inc. (Durham, NC)
- …efforts. Identify and share better practices, to include increasing awareness of data management standards & validation to create improvements in methods, ... & initiative to understand the site process control systems, data management systems, and differing data...within compliance with a quality mindset that focuses on risk management & mitigation Lead the training… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …methodologies and technologies to deliver actionable insights and propel data -driven decision-making.Promotes a culture of creativity and risk -taking, ... safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionWe are seeking an Associate Director, Program Management to drive the execution of critical drug development programs at ... seamless cross-functional coordination and execution.As a key member of the Program Management team, you will be responsible for translating strategy into execution… more
- Merck & Co. (Rahway, NJ)
- …quantitative systems pharmacology, model-based drug development (MBDD), or scientific data management .Proven experience leading cross-functional teams to launch ... (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We...scientific applications and lead squads to build user-friendly scientific data and technology products; handle risk assessment… more
- Repligen (Waltham, MA)
- …and supplier information. Data Analysis and Trend Reporting: Analyze NCMR data to identify recurring issues, high- risk suppliers, and common failure ... highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role… more
- Merck & Co. (Rahway, NJ)
- …activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject ... Control, Process Improvements, Quality Assurance (QA), Quality Assurance Systems, Quality Risk Management , Technical Writing, Test and Evaluation (T&E),… more
- Merck & Co. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … factors with and for other technical departments (eg, Clinical, Medical, Safety, Data Management , Statistics). This position requires skills in working in a ... fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing CROs in the RBQM space is also… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... all dosage forms (liquid, lyo, drug-device combinations)Review and approval of data and technical documentsAbility to recruit, select, develop, and mentor… more
- Merck & Co. (Durham, NC)
- …Skills:Business, Business Processes, Capital Planning, Clinical Supply Chain Management , Communication, Customer-Focused, Data Analysis, Financial Forecasting, ... the Supply Chain Logistics Strategy Leader will be responsible for the development, management , and growth of our warehousing and logistics operations, both on the… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist… more
- Merck & Co. (North Wales, PA)
- …lead team in key study planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site ... of status update reports, study close out activities).Leads team for timeline management , risk identification and mitigation, issue resolution.May facilitate and… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Aequor (East Syracuse, NY)
- …deliverables within given timelines. Ability to problem solve and apply risk -based critical thinking in a technical environment. Demonstrated history of continuous ... and process improvements. Document and evaluate experimental results and perform data verification and trending. Provide technical expertise and guidance to support… more
- Eisai, Inc (Nutley, NJ)
- …artificial intelligence to provide deeper insights, building Eisai's capabilities in Data Driven Decision Making aligned to brand strategy and investment priorities. ... The role will also be involved with Eisai Ecosystem data projects helping to provide analysis to uncover patient...issues but also meet key business criteria (eg, cost, risk , business impact) and key technical criteria (eg, reliability,… more
- Merck & Co. (Rahway, NJ)
- …-The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. ... following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... across clinical, commercial, and enterprise domains. This role involves applying data interpretation and trend forecasting to identify market trends, leading a… more
- Aequor (Houston, TX)
- …Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing. Management of multiple ... from both internal and external clients on the compiled final report. Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... enterprise technologies and will also be responsible for performing technical risk and vulnerability assessments at the network, system, and application level.… more
- Merck & Co. (Rahway, NJ)
- …(MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe ... of the audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex… more
