*Position: Quality Risk & Compliance Manager/Analyst* *Location: Durham, NC*
*Start date: 12/2* *Number of positions: 2 (two)* *Duration: long term - person is expected to be stable for long term as will only understand all SOP’s/regulatory guidelines over a period of time.* Excellent communication/interpersonal skills, as part of QRC team will work with IT & Business teams and several internal and vendor stakeholders. High level broad understanding of regulatory controls applicable in IT projects for pharmaceuticals industry– GAMP, SOX, (GMP/GCP/GLP), data privacy & security. This persons(s) will work with QRC team and will be involved right from planning of various IT project to provide regulatory oversight till execution to ensure all planned regulatory controls were implemented. Person will be managing portfolio of projects (8-10 projects), projects can be in any of the areas regulatory, clinical. SOX, IT control & securities. Involve in QRC Planning activities such as documents reviews, consulting and generating various metrics. Raise, maintain and promote high level quality solutions and services within the IT organization Participate to the implementation of controls described in the IT policies and procedures. Typical quality, risk and compliance areas include regulatory compliance (system validation), Sarbanes-Oxley compliance, security (continuity, record retention, data privacy, data protection), external facing system, outsourced IT services, software licensing and project management. *DISCIPLINE DESCRIPTION* Review a wide range of quality control tests and analyze to ensure that software meets or exceeds specified standards and end-user requirements Draft, revise and approve System Development Life Cycle deliverables, test plans and scripts to ensure alignment with standards and IT strategy Coordinate with users to adhere to project plans and key project milestones Ensure that system deliverables and tests are successfully completed and documented and all problems are resolved Test and monitor controls related to information security policies, procedures and systems KEY RESPONSIBILITES: Perform Risk & Compliance activities related to solutions and services implemented or managed by IT Assist GSK in the evaluation of IT Risks Assist GSK during audit and participate to inspection readiness program in IT Participate to internal audits and inspections as auditee Track key audit findings to resolution *QUALIFICATION REQUIRED FOR THOSE WHO PROVIDE THE SERVICE* A sound understanding of computerized information systems and (pharmaceutical) business processes Knowledgeable about current software and hardware risks, controls and procedures. Familiar with Pharmaceutical (GMP/GCP/GLP) and/or Financial (Sarbanes-Oxley) regulations Fluent in English Excellent oral and written communications skills ERP knowledge is relevant for the service Minimum of 2 years work experience in IT Risks or a related field IT Audit / Consulting experience is a plus Thanks Tejas Patel *X**Duce* -- You received this message because you are subscribed to the Google Groups "American Vendor--IT Consulting" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-vendor+unsubscr...@googlegroups.com. To post to this group, send email to sap-vendor@googlegroups.com. Visit this group at http://groups.google.com/group/sap-vendor. For more options, visit https://groups.google.com/groups/opt_out.
