Fiona Parker
Associate Director Global Development Quality Management @Regeneron
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WORK HISTORY
Associate Director Global Development Quality Management @Regeneron
EDUCATION
Oxford Brookes University
Master of Business Administration - MBA, Digital Strategy and Leadership; Project and Contract Management; Increasing Research Engagement
ABOUT FIONA PARKER
Experienced Quality Team Senior Manager / Quality Lead. Whole clinical trial life-cycle: risk adapted assessment; vendor qualification; protocol development; site setup and management through to site closure and archive. Quality support for cross functional teams: Project and trial clinical operations, Business development, Biometrics (DM/Stats), GCP laboratories, CMC and clinical trial supplies. Support for research and pre-clinical. Clinical trial essential trial documentation development. Vendor performance management. Lead annual global quality planning activities, to drive quality performance. Audit risk assessment; audit planning: cross-organization process; study specific; external vendor; audit lead and host.Develop, implement, and report quality key performance indicators.Lead continuous improvement initiatives and projects to improve processes and upgrade the quality documentation system to meet expanding quality activities. QMS Development: Policy and SOP author and reviewer. Quality by design and risk management. Early phase clinical trials, biotechnology, device trials, research studies. Process Improvement, trial specific and process driven audit; Change Control; Quality Event to CAPA. GCP for laboratories. Veeva Vault. ICH E6, E8, M10, Q9, Q10, FDA 21CFR, UK statutory instruments, EU directives/regulations/reflection papers.Global MBA at Oxford Brookes University: Dissertation - NHS Trust Engagement with Research. Final award: Distinction Prize: Best Dissertation
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