- Tris Pharma (Monmouth Junction, NJ)
- …standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event, ... product quality complaintsEngages in activities to continuously assess and improve quality systems by identifying and proactively resolving quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …up to date solutions. Oversee the testing strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with ... quality assurance teams to ensure that all non-regulated systems are thoroughly tested before deployment. Manage API based...that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals… more
- Merck & Co. (South San Francisco, CA)
- …experience in complex cellular model/assay development, mechanistic pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology) ... practices and leverage lab automation to improve assay operation, quality , and overall productivityIdentify, evaluate, and champion new enabling technologies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HCM Platforms and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS applications, possessing ... deep understanding of HR business processes, and business systems requirements. Accountable for global systems implementations inclusive of migrating from one… more
- Merck & Co. (Durham, NC)
- …expanding your career.Teknika vaccine manufacturing operations area is seeking a Lead Production Technician. The Teknika Facility manufactures vaccines , Onco Tice ... indicated for the treatment of Bladder Cancer and provide vaccination for Tuberculosis.As Lead Production Technician, this role will be the team co-leader in the… more
- Eisai, Inc (Nutley, NJ)
- …System Manager (CISM) certification is essential. Additional Certified Information Systems Auditor certification is advantageous.ISO 27001:2013 Lead Implementer ... hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio of IT Compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and precision ... to finding patients. Relationships Reports to Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including therapy area marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems ... Provide expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP ... area vision and message. Relationships Reports to the Integrated TA Strategy Lead . Responsible for providing interface with key internal and external stakeholders.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. ... portfolio. This role as CSO (Clinical Supply Planning and Operations) Project Lead is primarily responsible for developing and updating Study Supply Plans, managing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …many stakeholders.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Require minimal direction to complete ... for identified continuous improvement efforts associated with the manufacturing site. Lead assigned Quality tasks associated with process… more
- BioAgilytix (Boston, MA)
- …need them.BioAgilytix is seeking a detail-oriented and proactive GxP Laboratory Systems Administrator to suppport the administration, development, and deployment of ... our laboratory systems . This role plays a critical part in supporting...and standards.Support and system administration for identified applicationsPerform *and lead investigation and resolution efforts for technical and business… more
- Merck & Co. (Upper Gwynedd, PA)
- …least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.Knowledge and understanding of ... clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of...clinical development programs, clinical trial processes as well as quality management systems and quality … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and HEPA certification experience Proficient use of Asset Management and Quality Systems Strong understanding of industrial instrumentation HVAC, and ... Position Summary The Lead HEPA Certification Technician will provide direct leadership...analyzing existing measurement methods, and executing training as required Lead , develop, and support measurement methods in compliance with… more
- Merck & Co. (Rahway, NJ)
- …design and development processes (Design Control per ISO 13485, QMSR, Part 4). Lead quality oversight of product validation, verification, and risk mitigation ... of complex devices, such as auto-injectors and other complex drug delivery systems .Ensure adherence to quality standards and regulatory requirements throughout… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …many stakeholders.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Require minimal direction to complete ... requirements in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous improvement efforts, Quality site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for presenting at senior leadership meetings.Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all ... regulatory submissions and / or inspections Ensures that appropriate systems , processes are in place to enhance GLP/GCLP activities... Quality leadership team c. Develop/ chair or co- lead quality council as necessary.Ensure the vision… more
- Aequor (Bothell, WA)
- …asset management activities for the support of benchtop equipment and lab and quality systems .Execute and update documentation for the support of benchtop ... equipment and lab and quality systems to ensure assets are reliable,...work assignments as a point of contact for project stakeholders. Lead or provide supporting activities within the quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe User Experience Product Line Lead is a core and leadership position in Digital Services, our Digital Manufacuring Division responsible for leading ... strategy in our Digital Manufacuring Division.- The Product Line Lead drives priorities setting and holistic value delivery of...Division and IT to develop, test, and deliver high quality , scalable, and reusable data and digital products Oversee… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support customer experience (CX) campaigns, ensuring seamless integration with other systems . The lead analyzes customer journeys to identify optimization ... Are you ready to experiment with us? The Position The CX Functional Lead is responsible for developing and executing MarTech strategies that enhance customer… more
