- Lead the development and maintenance of processes and standards for the R&D IT organisation referring to appropriate industry standards e.g. COBIT, ITIL, GAMP5 and regulations e.g FDA, MHRA, EC.
- Facilitate the maintenance and deployment of the IT Quality Manual and Systems Development Lifecycle for R&D IT
- Provide guidance to enable the organisation to apply standards / meet regulations and to address non-compliance issues on the use of computerised systems proportionately to their impact and the needs of the business
- Support IT Delivery in the use of the SDLC to assess, plan, coordinate and perform the computerised systems validation of systems being implemented, from project inception with IT Demand through to handover with IT Services including
- Criticality and Business Risk Assessment of requirements
- Validation PlanninG
- Design Review
- Test Planning (including design and scripting of functional testing)
- Traceability of validation activities through to design/configuration, and testing.
- Validation Reporting and hand-over to system owner and IT Service
- Maintain the state of 'inspection readiness' by regular and ad-hoc review of IT's compliance state, outstanding corrective actions, and identifying preventative actions to prevent issues arising during inspection.
- Act as primary contact during regulatory inspections for any matters relating to the control of computerised systems.
- The role requires strong Audit, Risk and Controls skills; strong interpersonal and engagement skills at internal and external levels are essential.
- Degree Educated, with 8-10 years post graduate work experience in a Pharmaceutical/Life Sciences/Medical Device Industry
- Experience of specific industry best practice