- Insmed Incorporated (San Diego, CA)
- …Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team ... strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- Insmed Incorporated (NJ)
- …will include, but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and ... Work Instructions Coordinate all validation activities with outsourced validation vendor when...in the CSV SharePoint site, managing CSV documents in Veeva , routing documents for review and approval in … more
- Merck & Co. (Rahway, NJ)
- …(eg, VMs), databases/historians, and basic system administrationExperience with electronic validation and quality systems (eg, Kneat/eVal, Veeva )Prior leadership ... automation representative for new products, process changes, and operational improvements; lead cross-functional teams and participate in tier meetings to drive… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from ... 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in… more
- BeOne Medicines (San Mateo, CA)
- …and operational excellence. **Essential Functions of the job:** + Lead process improvement/optimization projects from inception to implementation to improve ... related experience preferred. **Computer Skills:** High Level of Competency Required: + Veeva Vault Experience Preferred + Microsoft Office and Adobe systems +… more
- GRAIL (Durham, NC)
- …820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards. + Lead regularly scheduled meetings to ensure timely and compliant completion of ... training and competency programs for the CAPA and NCR processes. + Lead software system configuration maintenance and improvements, including testing and … more
- BeOne Medicines (Pennington, NJ)
- …BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support technology transfer, ... validation , continued process verification, investigations, change management and manufacturing...as MST DP Subject Matter Expert (SME) and process lead for drug product, ensuring the materials, strategy and… more
- Cognizant (Boston, MA)
- **About the role** As a ** Validation Lead with Veeva DMS/QMS / Veeva Clinical** , you will make an impact by driving the validation strategy and ... validation processes. **In this role, you will:** . Lead the testing strategy for Document Management Systems, ensuring...need to have to be considered** . **Experience with Veeva Clinical or Veeva DMS/QMS platforms.** +… more
- Insight Global (Rahway, NJ)
- …support during hypercare. * Cross-Functional Collaboration Coordinate with the Integration Lead to connect Veeva Vaults (Clinical, Quality, Safety). Participate ... a Business Analyst for a long term contract to support the implementation of Veeva Vault RIM Submissiions. This candidate will have a specific focus on authoring… more
- Insight Global (Upper Gwynedd, PA)
- …This role is critical in planning and mapping regulatory submission processes to Veeva best practices. Key Responsibilities: * Lead submission planning across ... multiple markets (eg, RDA start, PSPM planning) within Veeva . * Analyze current processes and define how they will transition into Veeva , including writing user… more
- Cognizant (Bridgewater, NJ)
- …seeking a seasoned **Test Lead ** to oversee the testing efforts for Veeva Vault Safety implementations. The ideal candidate will have strong experience in life ... strategy development. **Experience Level:** 8+ years in Testing **Key Responsibilities:** + Lead end-to-end testing activities for Veeva Vault Safety projects. +… more
- Capgemini (Danbury, CT)
- …Take full ownership of the finalized test strategy and plan for the Veeva CRM to Vault CRM migration across multiple workstreams. Drive execution, coordination, and ... deliverables are met on schedule. + Operational Leadership + Coordinate and lead all testing activities across business, application, interface, and US IT… more
- Cognizant (Boston, MA)
- **About the role** As a ** Validation Lead - MES Serialization** , you will make an impact by leading the testing and validation strategy for enterprise-level ... and business teams across global locations. **In this role, you will:** + Lead the testing strategy for Document Management Systems, ensuring robust, compliant, and… more
- J&J Family of Companies (Raritan, NJ)
- …with cross-functional teams. + Oversee the end-to-end deployment process of Veeva releases, including pre-release testing, validation , and post-deployment ... is seeking a Technical Product Owner, Regulatory Excellence Release Management and Support Lead , located in Raritan, NJ (preffered) or Titusville, NJ. At Johnson &… more
- Insight Global (Midlothian, VA)
- …Global is seeking an IT Compliance Lead local to Richmond, VA. This lead is highly skilled in Computer Systems Validation (CSV) with strong GxP experience ... IT teams, Quality, and Regulatory functions to define computer system validation requirements and ensure IT project delivery, application management and change… more
- Sanofi Group (Morristown, NJ)
- …between regulatory SMEs, business process owners, and digital product teams, and lead the development of scalable and compliant solutions that support Sanofi ... workshop programs and testing strategies to support solution development and validation . **Compliance & Operational Excellence** : + Develop enterprise compliance… more
- Sumitomo Pharma (Frankfort, KY)
- …**_This role requires proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (eg CTMS, EDC etc.) in a regulated environment_** ... through their full lifecycle, from implementation to ongoing optimization + Lead and initiate troubleshooting quality and/or functionality issues associated with… more
- Bristol Myers Squibb (Devens, MA)
- …Read more: careers.bms.com/working-with-us . **Position Summary** This position is a lead level technical individual contributor and technical project lead ... the DeltaV, PI, BAS, and integrated process equipment. **Duties/Responsibilities** + Technical lead and subject matter expert for the process automation systems and… more
- Sokol Materials & Services (Skillman, NJ)
- QA Lead Technical Operations - CAPA Job Location Devens, MA Workspace On-site position (no remote or hybrid options) Target Hiring Date July 14, 2025 Work ... Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic, or paper-based batch records desirable. + Excellent… more
- ThermoFisher Scientific (San Diego, CA)
- …periods. + Generates stability protocols, reports, and presentations. + Ability to lead multiple stability programs with moderate to high complexity within CMC. + ... + Experienced user for document management systems such as Veeva Quality and Veeva RIM. + Supports...audit functions, as needed. + Serves as a stability lead for a CMC project team or a working… more
