- Exela Pharma Sciences, LLC (Lenoir, NC)
- …resources needed to make improvement to existing systems as needed. This role is the site Subject Matter Expert ( SME ) for site GMP Clean Utilities ... product and efficiency of operation. Responsibilities will include:Strong technical skills, be the Subject Matter Expert ( SME ) from equipment… more
- Formation Bio (New York, NY)
- …GMP QA strategy and execution for Formation Bio's portfolio. Acting as the QA subject matter expert , this role supports CMC development activities, including ... a culture of quality excellence, accountability, and continuous learning. Serve as the QA subject matter expert for all CMC-related quality activities and… more
- Modern Technology Solutions, Inc. (Moraine, OH)
- …ISs to periodically verify that security features and operating controls are functional and effective. * Shall utilize security-related software for the detection of ... malicious code, viruses, and intruders, as appropriate. * Shall provide technical expertise to assist in applying and implementing JSIG requirements into the security structure of the Platform ISs. * Shall support the maintenance and development of SSPs for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …gather, document, implement and validate all system requirements for associated module(s).Serve as the Subject Matter Expert ( SME ) for respective modules ... an outstanding end-user experience.Responsibilities- HR Systems ManagementAct as the principal functional expert and advisor for implementation and ongoing… more
- Genmab (Plainsboro, NJ)
- …competency development.Lead functional working groups; serve as process owner or Subject Matter Expert ( SME ) within Clinical Operations.Support ... and managing complex global clinical projects/programsSignificant experience managing/guiding internal (cross- functional ) and external (CRO, regulatory authorities) teamsExperience with operational… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …consultation on inter-site projects & is considered to be SAP Supply Chain Management (SAP SCM) Subject Matter Expert ( SME ) at API M2-US. Serves as local ... for future requirements to mitigate them Tests SAP SCM system updates & functional changes to ensure the system continues to meet business objectives & user… more
- Twist BioScience (South San Francisco, CA)
- …to meet business requirements and work with users to gain UAT sign-off.Serve as the subject matter expert for key SAP FI/CO modules and processes.Serve as ... and PP.Good understanding of SAP integration with third-party systems.Prepares functional specifications for conversions and enhancements, as well as...the technical subject matter expert for Finance… more
- Formation Bio (New York, NY)
- …a culture of quality excellence, accountability, and continuous learning. Serve as a subject matter expert on quality assurance matters during regulatory ... compliance with requirements. About You Strategic and creative thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives ... Qualification Protocols) with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role assignments in the Clinical Data Repository. Functional Expertise: Serve as a subject matter expert and provide oversight and technical support in ... the Biostatistics and Data Management Data Operations team and serves both as a subject matter expert and leader of a group responsible for the business… more
