- Novo Nordisk Inc. (Durham, NC)
- …& Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better practices, to include ... increasing awareness of data management standards & validation to create improvements in...within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation… 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
- 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)
- …and/or regulatory inspections. Independently performs audits of batch documentation, data , information, procedures, equipment and systems, and/or facilities to ... filings. Perform independent quality review and approval of batch records, testing data , and related documents required to release or reject product. Make… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function ... different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface… 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 will also ... 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. (San Francisco, CA)
- …execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational ... team build and manage digital tools that enhance operational efficiency and data -driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt… 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. (Durham, NC)
- …Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Insmed Incorporated (San Diego, CA)
- …guidelines.ResponsibilitiesResponsibilities (Essential Role Responsibilities):Establish and maintain a risk -based and scientific-based quality system to support ... and development of adverse trends) to ensure patient safety and data integrity.Supports strategic direction with cross functional working groups to identify… more
- Formation Bio (New York, NY)
- …solutions to common program challenges, including resource constraints and risk mitigation strategies. Develop contingency plans for critical program elements ... planning for major program decisions. Synthesize technical, financial, and operational data to drive decision-making. Manage ambiguity by proactively identifying … more
- Formation Bio (New York, NY)
- …maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor compliance with company ... policies, industry regulations (eg, FDA, EMA, GxP), and data security requirements. Identify opportunities for cost savings, contract optimizations, and risk … more
- Merck & Co. (Durham, NC)
- …Financial audits, input to QSAT actions, to ensure compliance.Support the Master Data team with general Material Handling Steward tasksDrive safety, quality and ... process efficiencies and drive enhancements in storage capabilities.Work closely with master data center of excellence (COE) and site integrated process teams (IPT)… more
- Merck & Co. (Rahway, NJ)
- …candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This ... 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
- Merck & Co. (North Wales, PA)
- …in key study planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site materials, ... reports, study close out activities).Leads team for timeline management, risk identification and mitigation, issue resolution.May facilitate and collaborate with… 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
- Aequor (Houston, TX)
- …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) ... and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing. Management of multiple projects and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be ... responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of… more
