Danielle Grindley
Central Monitoring Lead @Astellas Pharma
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WORK HISTORY
Central Monitoring Lead @Astellas Pharma
EDUCATION
The University of Sheffield
Postgraduate Diploma in Public Health
Northumbria University
BSc (hons) Biomedical Science
ABOUT DANIELLE GRINDLEY
Please note content and comments expressed on this page are my own and not representative of Astellas * I’m an experienced Risk-Based Quality Management (RBQM) professional in the pharmaceutical industry, specializing in driving RBQM adoption, central risk surveillance, and quality risk governance for global clinical trials. I have a proven track record of partnering with cross-functional teams to identify and mitigate critical-to-quality risks, implement IQRMPs, define QTLs/KRIs, and conduct ongoing risk surveillance. My experience spans working closely with study teams, data analytics experts, and system configuration teams to ensure robust, inspection-ready quality oversight. • 4+ years of hands-on RBQM implementation and leadership • Expertise in GCP compliance (ICH E6/E8, 21 CFR Part 11) • Strong record supporting audits & inspections, driving CAPA implementation • Collaborative leader who coaches teams to embed RBQM into study culture • Passionate about transforming trial quality through better data, analytics & proactive governance
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