- CGI Technologies and Solutions, Inc. (New Brunswick, NJ)
- …. **Position Description:** CGI is seeking a Subject Matter Expert (SME) IT Lab Support Specialist to join ... system processes expertise. Location: Rahway, NJ **Your future duties and responsibilities:** Expert -level analyst supervising lab IT support teams and managing… more
- Sanofi Group (Morristown, NJ)
- …+ Compliance of Computerized systems (REMS, GDPR, PHI, PII, GxP ) + Patient Service/Healthcare experience desired **Transversal Skills & Competencies / Soft ... cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The role ensures that our… more
- J&J Family of Companies (Raritan, NJ)
- …Develops and maintains assessment tools for the qualification and validation of conveyed IT GxP systems + Applies comprehensive risk management approaches and ... Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital… more
- Catalent Pharma Solutions (Somerset, NJ)
- …project teams, suppliers, site quality and IT teams acting as an expert on quality, regulatory, and compliance resource, bringing forth opportunities for the ... validation, implementation and ongoing maintenance and use of computerized GxP systems and IT infrastructure; Oversee quality...internal and supplier audits as a compliance , IT and CSV subject matter expert and… more
- J&J Family of Companies (Raritan, NJ)
- …+ Process oriented + Supply Chain experience + Knowledge of CSV, SOX, and GxP compliance requirement + Strong Analytical Skills, with technical competence + ... solutions and approved system improvements + Collaborate with commercial, supply chain, compliance , and IT organizations to develop end to end strategic… more
- Sanofi Group (Morristown, NJ)
- …full compliance with Sanofi policies, with particular attention to GxP , privacy, and anti-kickback areas. **Specific Expectations for Data Operations** + Senior ... program leader should be a "consultant level" subject matter expert in their operations and/or data domains. They are...**Resource Management:** + Effectively manage and optimize all resources. ** Compliance :** + Ensure all data and services are in… more
- IBM (New York, NY)
- …and customers through complexity to get results. - Understanding of life sciences compliance and computer systems validation requirements (eg, GxP , GcP). - ... develop unstructured requirements into quality requirements and translate business requirements to IT terms. - Use data analysis tools to gather insights and support… more
- Insight Global (Scotch Plains, NJ)
- …dispersed. Mentor, coach, and teach other technical team members on best practices/principles. Ensure IT compliance (WICO, HIPAA, GXP , 21 CFR Part 11, ... software to Medical Device manufacturing sites globally. Act as subject matter expert on system design and architecture. Solutioning and designing new functionality.… more
- Sanofi Group (Morristown, NJ)
- …as necessary, and communicating changes clearly and professionally. + Provide expert knowledge of technical and application architecture to the various development ... of delivering solutions in this space. + Knowledge of GxP , HIPAA, and GDPR regulations and the ability to...HIPAA, and GDPR regulations and the ability to ensure compliance with these regulations in the design and implementation… more