Directing a team of computerised system strategists, who in partnership with business areas, identify, assess and collate positive evidence of data integrity, whilst identifying risks and opportunities and use innovative approaches to provide quality positions for regulatory authorities and other stakeholders v areas of most impact to achieve business goals of successful product approvals, safety profiles and retaining regulatory compliance including Computerised systems (GCP, PV, GMP, RWD/RWE, AI/ML SamD).

Directing a team of computerised system strategists, who in partnership with business areas, identify, assess and mitigate risk relating to computerised systems and of data integrity, whilst employing innovative risk based approaches to ensure processes and systems are fit for purpose, and pass regulatory authorities scrutiny to achieve business goals of successful product approvals, safety profiles and retaining regulatory compliance including Computerised systems (GCP, PV, GMP, AI, RWD.

Global role responsible for the development and implementation of risk based quality assurance (QA) strategies for computer validation and operational processes, computerized systems and suppliers that support regulated GLP, GCP and Pharmacovigilance (PV) activities.- Providing leadership and direction to a global team of Computerized System Strategy Leads and ensure consistent execution of the department strategy.- Resources management and objective definition to maximize the value and impact of compliance information resulting from the risk and audit strategy. - Management, support and development of staff- Establishment and ensuring consistent application of the necessary risk assessment tools and processes to identify the need and set objectives for audit and risk mitigation activities.- Building strong partnerships with key stakeholders across the Roche organisation - Applying innovative techniques to assess risk. - Communication of compliance trends and review of plans for risk mitigation. - Taking ownership of and leading on complex quality issues. - Providing quality management oversight to teams working on related projects.

Global position In Pharma/Biotech company.Leading external GCP CRO audits - Histopathology, Biomarker and Imaging Laboratories, Central Laboratories, Clinical trial sites, Strategic Partners for Outsourced trials, Clinical CROs, IVRS/IWRS, Ethics board, Informed consent, CPUs, Data Management, Computerised SystemsLeading Global Internal process audits, Affiliate (Marketing Company) auditsInternational audits with multidisciplinary teams across all clinical phases.Clinical Programme Contact QA lead Recruitment and training of expanding auditor pool.

Global positionLeading external GCP CRO audits - histopathology and biomarker and imaging central laboratories, Clinical trial sites, IVRS/IWRS, CSV, Ethics board, Informed consent, CPUs, Data Management internationally with multidisciplinary teams accross all clinical phases. Strategic realignment of FRO audit programme and process. Recruitment and training of expanding auditor pool

Programme QA lead for IT Transformation project to exit multiple closure sites involving multiple internal and external partners. Ensure exit is controlled, satisfies regulatory requirements whilst meeting defined deadlines. Ensure regulated & business critical IT systems and infrastructure are transferred, decommissioned or archived.Quality Adviser to the Symbicort established Brand programme. Ensuring the QA requirements of multiple studies using global, complicated supply chains and multiple internal and external partners are met, Anticipation and removal of blockages to meet first subject in dates and product enhancements.

Designed and faciliated ISO9001 lead auditor course for pharma and general but also designed for IT auditor focus to improve company capability.Interpreted regulatory requirements and guidance into company procedures and processes e.g. GAMP, Requirements for Clinical Systems validation, orange guide annex 11 computerised systems.Reviewed and recommended a global IT continuous improvment Quality managment system for the international sales and marketing organisation for deployment accross 61 sites.Led first global IT internal audit and audited company wide systems and IT processes.For cause (troubleshooting) audits of external partners and internal processes.Built and maintained relationships and feedback loops between business areas and IT.

Global R&D supply chain programme Quality managerComputerised systems global QA expertGlobal QA lead for efficiency projectRisk management ambassadorSteering group and change board member for various IT systems.Quality KPI collation and reporting Drug development project QA including release of raw material, API, bulk product and final packed clinical trial supplies.Internal and external auditorSet up and management of various quality systems including audit, deviations, complaints, change control, batch release.