- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high ... standards of data quality and compliance within Global R&D...to foster a culture of compliance and accountability in data management practices. The position also involves… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleThe Associate Director, External Data Quality Management , is a strategic leadership role within Clinical ... with external vendor management a plus.Proven expertise in protocol design, data quality management , and protocol deviation oversight.Strong knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming ... reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug development process.Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials ... to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are consistent and regulatory compliant across studies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of clinical development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations for ... oversight of CROs pertaining to laboratory data management , LNR collection standards, and quality issue...expertise in the resolution of lab related inquiries and issues such as conversion factors, translations, and textbook ranges.-… more
- Tris Pharma (Monmouth Junction, NJ)
- …Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, ... management principles in design (and resolution) of key quality management system elements to ensure complianceTracks... quality systems by identifying and proactively resolving quality issues Develops, analyzes and compiles … more
- Aequor (Thousand Oaks, CA)
- …actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will ... of equipment in area of expertise. 15. Extensive knowledge and application of SAP Quality Management (QM) Module 16. Advanced skills in solving complex problems.… more
- Merck & Co. (Rahway, NJ)
- …and our company's requirements while driving continuous improvement in Device Supplier Quality Management .- Accountable for other Quality Programs, as ... are compliant.Participates on our teams supporting MDCP cGMP and quality issues related to pure Medical Devices...820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management System documents for the … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experienced quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Regulatory Compliance, Policy Development, Process Facilitation, Process Improvements, Quality Improvement Programs, Quality Management , ... Job DescriptionOur Quality Assurance Group ensures every single material inside...in a pharmaceutical or biotechnology manufacturing site.--Strong background in data analyticsDemonstrated ability to creatively use multiple methods of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Word, PowerPoint, Excel, OneNote, Project, and Teams Requires demonstrated computer skills with data management systems or data bases Ability to utilize ... is responsible for maintaining and advising new projects on the Building Management System while collaborating with the Engineering team to provide necessary… more
- Merck & Co. (Boston, MA)
- …Quantitative systems pharmacology, Model-Based Drug Development-, or scientific data management .Experience leading cross-functional teams, launching, and ... Research and Development Sciences (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We enable data ,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …groups, CROs, Affiliates in order to ensure high data quality and proactive detection and resolution of issues .External Engagement:Continuously review ... between R&D and Medical affairs, particularly in case when issues impact Medical Affairs programs. Ensure requirements are in...process improvements to stakeholders via the QMS framework (ie, Quality Management Review, Quality Review… more
- Merck & Co. (Rahway, NJ)
- …and analyzing system and passive data governance reports to ensure high quality data and timely and complete synchronization between systems. Acts to resolve ... all issues and discrepancies as data stewards responsible...Analytics technologies, including SACP, Datasphere, SAP BW, HANA, Master Data management and ECC. Strong understanding of… more
- Twist BioScience (South San Francisco, CA)
- …to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems.Superior interpersonal skills and ability to develop ... direction.Communicates project progress on behalf of core teams to senior management regularly.Proactively identifies any technical/resource issues , concerns or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... in compliance with CDISC and submission requirement, review submission data package and ensure its quality and...quality , proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and… more
- Merck & Co. (Durham, NC)
- …and key performance indicators. Benchmark performance indicators against industry data . Look for continuous improvements opportunities RESOURCE MANAGEMENT : ... The site includes an Energy Center, Fill Finish Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage… more
- Merck & Co. (Durham, NC)
- …Partner).-- Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Merck & Co. (Durham, NC)
- …from the team members, while maintaining a focus on Safety First and Quality Always.Identify root causes of manufacturing issues and implement corrective action ... Manufacturing Practices (GMP), Interpersonal Relationships, Inventory Management , Management Process, Manufacturing Processes, Manufacturing Quality Control,… more
