- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:We're looking for a GxP Clinical Systems IT Owner in the IT team to ... Systems & Business Intelligence, you'll be responsible for ensuring that clinical IT systems are implemented, validated and maintained in compliance… more
- Merck & Co. (Rahway, NJ)
- …validation, change control, and testing documentation in partnership with project CQV and IT teams.Support establishment of GxP systems in the facility: ... Change Management, Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems .Lead integration of control systems with… more
- Insmed Incorporated (NJ)
- …EU GMP Annex 11, and GAMP 5 guidelines a plus .Experience collaborating with Quality, IT , and business stakeholders to ensure systems are validated and remain in ... leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage cross-functional teams… more
- Merck & Co. (Rahway, NJ)
- …and supporting corrective actions for investigations related to automation or IT systems .Conduct or support automation system-related investigations and ... Job DescriptionThe Associate Director, Automation within Global Clinical Supply (GCS) is responsible for developing and...Supply (GCS) is responsible for developing and executing a systems and process automation strategy to support new and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Historian, IOT, etc. ) and a willingness to learn and adapt to new Biologics Clinical Manufacturing IT systems as they emerge + Extensive knowledge of ... Join Gilead and help create possible, together. **Job Description** The **Sr IT Business Analysis Specialist (Tech Dev Biologics Clinical Manufacturing)** in… more
- Bristol Myers Squibb (Devens, MA)
- …or related field. + 7+ years of experience managing laboratory IT systems in a GMP or GxP -regulated pharmaceutical manufacturing or research environment. + ... lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager, Benchtop IT Systems at the Devens Cell Therapy Facility is… more
- CGI Technologies and Solutions, Inc. (Boston, MA)
- …experience managing projects in one or more of the following areas: o Clinical systems (eClinical, EDC, CTMS, eTMF) oR&D / laboratory / translational ... ** IT Project Manager - Life Sciences** **Category:** Project...PMP, PRINCE2, SAFe, CSM, or PMI-ACP. . Experience with GxP / validated systems and familiarity with… more
- System One (Princeton, NJ)
- …in transition, with responsibility for restructuring, mentoring, and developing a high-performing IT organization to support clinical systems and digital ... a high-performing IT organization that can support our mission-critical clinical systems and digital transformation initiatives. This role is ideal… more
- Eurofins US Network (Kalamazoo, MI)
- …, DNA analysis, digital microscopes, UV plate readers, HVAC and robotic/automation systems . + Experience installing and maintaining GxP -validated systems . ... CDMO, advanced material sciences and in the support of clinical studies._ _If you're looking for a rewarding career,...backup and recovery software for all complex and critical systems . 6. Builds various testing and monitoring utilities using… more
- Cardinal Health (Phoenix, AZ)
- …and products company. We provide customized solutions for hospitals, healthcare systems , pharmacies, ambulatory surgery centers, clinical laboratories, physician ... Professional certifications preferred: CGEIT (Certified in the Governance of Enterprise IT ), CISA (Certified Information Systems Auditor), CISSP (Certified… more
- Bausch + Lomb (Bridgewater, NJ)
- …reduce complexity, enhance data flow, and improve decision-making. Oversee technology support for GxP Clinical and regulatory compliance in the context of global ... eye health in the future. Bausch + Lomb is seeking an innovative and forward-thinking IT executive to serve as Vice President, Global IT Lead for Manufacturing,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr. Director, Global Clinical Supply Chain, GCO ( Global Clinical Operations) Date: Dec 20, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: ... with. **The opportunity** We are seeking an experienced Senior Director/Head, Global Clinical Supply Chain to lead end-to-end clinical supply operations across… more
- Actalent (Alameda, CA)
- …to internal and external customers and partners. + Utilize appropriate software and IT systems to effectively manage key project activities. Essential Skills + ... and packaging vendors. + Maintain traceable documentation to support GXP activities. + Potential opportunity to manage clinical...and approval processes. + Knowledge of Interactive Voice/Web response systems for use in clinical studies. +… more
- Bristol Myers Squibb (Devens, MA)
- …enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would ... and technical support. + Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …Oversee the development and global deployment of training programs in: + GxP (Good Manufacturing/ Clinical /Laboratory Practice) compliance + Ethics and Compliance ... and execution of a Center of Excellence (CoE) for GxP & non- GXP learning and development. The...Partner with Quality, Regulatory, R&D, Manufacturing, Supply Chain, and IT to ensure training programs are aligned with business… more
- System One (Princeton, NJ)
- …Role We're seeking an experienced Lead Validation Specialist with a strong background in clinical systems and computer systems validation to join our growing ... 11. + Develop, execute, and maintain validation strategies and documentation for clinical systems . + Collaborate cross-functionally with developers, QA, and SMEs… more
- Kelly Services (Winston Salem, NC)
- …analyst will maintain accurate data, support investigations, ensure compliance with cGMP/ GxP requirements, and contribute to continuous improvement within the QC ... and support deviation and OOS investigations within electronic quality systems . + Support completion of action items and AQEM...or medical device industry. + Strong understanding of cGMP, GxP , and FDA regulations. + Familiarity with bioassays and… more
- Merck (Rahway, NJ)
- …with project CQV and IT teams. + Support establishment of GxP systems in the facility: Change Management, Maintenance protocols, Calibration procedures, ... biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical , and Early Development to rapidly develop processes for...Training, and SOPs for all GxP automation systems . + Lead integration of… more
- Sumitomo Pharma (Frankfort, KY)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Manager, Clinical Systems R&D IT Business Applications** who will serve ... as the primary liaison between R&D Clinical Operations team and IT , responsible for...proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (eg CTMS, EDC etc.) in… more
- Lilly (Indianapolis, IN)
- …* Knowledge of GxP , Pharmaceutical manufacturing processes and automations systems . **About the Organization:** Lilly IT builds and maintains capabilities ... insights, inspection readiness, and operational excellence while ensuring they meet stringent ** GxP , data integrity, and compliance standards** . This is a strategic… more
