- Merck & Co. (Ames, IA)
- …Technical Support and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program:ResponsibilitiesPerform ... oversee both internal and external auditing and Animal Health Supplier Quality Management .- Required QualificationsBachelor's degree (a degree in Engineering,… more
- Merck & Co. (Rahway, NJ)
- …work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues /trends.-Specific and/or additional duties may include, ... quality and our company's standards and communicate project status to management .Act as Development Quality representative for in-house or outsourced… more
- Repligen (Rancho Dominguez, CA)
- …for effective inspection and testing.Compiling and analyze data related to quality and manufacturing issues and initiate CAPA. Monitor and verifies the ... tools and scientific/technical investigations.Experience/training in quality planning, CAPA, quality auditing, root cause analysis, and statistical data … more
- Merck & Co. (North Wales, PA)
- …final versions and - congress QR code process. Assist with reference requests, bibliography management , posting of study data - packages for author access and ... and written communication Ability to know when and how to appropriately raise issues to team and to management Ability to communicate complex medical/scientific… more
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... questions and issues related to submission content management , quality and standards complianceEngage across functional...process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where… more
- Insmed Incorporated (NJ)
- …cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development ... QA activities.Support investigations and root cause analysis of product or process issues related to clinical manufacturing.Drive Quality input into lifecycle… more
- Merck & Co. (Rahway, NJ)
- …quantitative systems pharmacology, model-based drug development (MBDD), or scientific data management .- Proven experience leading cross-functional teams to ... Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, Scientific Data Management , Scientific Software… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …etc.)-Ensure operational study-level timeline, budget, deliverables and quality management -Facilitate escalation and resolution of issues with CRO/ vendors/ ... the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead...with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to ... standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of ... maintaining compliance and quality .Must be able to discern the criticality of issues and communicate to management regarding complex issues .Ability to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implementing study/program-specific quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA ... Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial...stakeholders and CROs to ensure high data quality , proactively identifying and resolving issues throughout… more
- Novo Nordisk Inc. (Seattle, WA)
- …and symposia: a) ensures and maintains thorough knowledge of the latest and current issues and new data pertaining to NNI products; b) develops, establishes and ... 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
- Genmab (NJ)
- …on data standards, reporting and analysis standards, change control management and related tools/applications Creates quality control processes, metrics and ... to support the portfolio towards the ultimate objective of data quality and consistency across programs and...Serves as a liaison between Clinical Programming and External Data Management to ensure data … more
- Repligen (Waltham, MA)
- …cases and common troubleshooting scenariosContinuous ImprovementPartner with Field Applications, Quality and Strategic Product Management to translate customer ... (resin packing experience a plus)Proven ability to troubleshoot and resolve technical issues in a customer-facing roleAnalytical and data -driven mindset with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management :Develops talent through providing focused career development, performance management and manages retention.Fosters a high- quality culture ensuring ... immune disorders. Job Summary: Provides operational oversight to study management personnel within assigned program(s). Provides managerial oversight to colleagues… more
- Merck & Co. (Durham, NC)
- …from the team members, while maintaining a focus on Safety First and Quality AlwaysIdentify root causes of manufacturing issues and implement corrective action ... role's pay range.#MSJRVETJOBSRequired Skills: Adaptability, Adaptability, Aseptic Manufacturing, Business Management , Business Planning, cGMP Compliance, Communication, Data … more
- Repligen (Waltham, MA)
- …remediation strategies.EducationBachelor's degree required.Preferred (not required): certifications in data management or business intelligence (eg, CDMP, ... improvements, automation opportunities, and standardization across ITGC and SOX processes.Utilize data analytics to enhance testing quality , reduce risk, and… more
- Cipla (Fall River, MA)
- …new technologies and automation in production workflows. Collaborate with Team, Quality , Supply Chain, Project Management , Engineering, and R&D teams ... Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards. Identify and resolve operational inefficiencies, escalating complex issues… more
- Cipla (Hauppauge, NY)
- …the batch record review process, particularly in relation to audit trail management and data integrity. Ensure completion of individual training assigned ... compliance, and performance of IT systems, contributing directly to product quality and regulatory adherence. You will primarily be responsible for validating… more
