Develop and maintain compliance of BBI IT systems to the relevant SOX controls, IT security, Data Integrity and GxP standards e.g. 21 CFR Part 11, EU GMP Annex 11 and GAMP 5. To assure controls and testing meet industry regulations and systems are fit for purpose. Ensuring IT systems are monitored for changes and vendors are qualified, so as to assure BBI Data is secure and controlled. Specific focus on Data integrity, Clinical systems, Data management (EDC and Data Transfer controls), IT security and infrastructure qualification on a risk based phase appropriate approach. Author (as needed), review and approve qualification and validation documentation in a timely manner ensuring compliance with SOX, Data integrity, IT security and GxP standards and industry expectations for IT compliance. Effectively communicate with other departments within BBI on IT compliance and possible IT validation concerns. Ensure any testing errors, deviations from SOP's or IT Compliance observations/non-conformances are properly investigated and explained. Actively lead and set tactical guidance on IT Compliance and Computer system validation for BBI IT GxP Projects. Support testing execution, including training testers. Be the IT Compliance CSV SME for BBI business users and IT teams. Evaluate IT change control documentation for compliance/validation/GXP impact and determine validation requirements for that change. Participate in IT project meetings and give input on QA issues related to CSV. Support the development and implementation of corporate policies, SOP's and working practice documents to facilitate continuous improvement of performance and compliance related to Data integrity, Clinical systems, Data management (EDC and Data Transfer controls), IT security and infrastructure qualification.
Excellent communication and technical writing skills, flexible and pragmatic communication ability Ability to manage priorities time effectively to meet set goals and timelines. Ability to work collaboratively with other functions on a global level, influencing buy in from third parties to produce planned outcomes. Ability to use personnel insight to conceptually solve problems and suggest appropriate solutions beyond standard approaches based on risk and phase appropriate needs. Ability to recognize where input is required at a more hierarchically senior level, escalating appropriate issues to Head of IT Compliance, offering proactive solutions. Experience of working with Quality Systems (CAPA, Dev, Change Control), GCP, GLP, GMP and PV Experience with GAMP5 and Annex 11, Part 11: deliverables such as PQ, IQ, OQ, UAT, Val Plan, Val Summary Report, Trace matrix, Risk assessment, Change controls, periodic review Technical experience: Mastercontrol, Veeva (eTMF & Quality), Oracle inform, EDC solutions, Argus, SAS, Stability programs, Software as a service (Cloud) solutions and hosted solutions, Trackwise, Sharepoint, Excel, Office 365, Clinplus, Vendor configured or hosted solutions and vendor qualifications. SOX, IT Security and Data mangement , Data Integrity and clinical systems Associated topics: attorney, attorney corporate, compliance, compliance department, internal, legal, legal affairs, legal department, llp, market
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