Aldwin Aldana, MS, RQAP-GLP, RQAP-GCP, currently serves as Director of Clinical Development Quality Assurance and Compliance at Invivyd, overseeing clinical quality assurance and compliance efforts. With a robust background in clinical quality assurance across various organizations, Aldana has held significant positions such as Director of Clinical Quality Assurance at Bolt Biotherapeutics and Senior Director at Immunovant, where responsibilities included developing risk-based GCP oversight processes and managing GCP audits. Aldana's experience spans numerous companies including Ultragenyx Pharmaceutical Inc., Biogen, and EMD Serono, emphasizing expertise in ensuring compliance with regulatory standards and maintaining inspection readiness. Aldana holds a Master’s Degree in Regulatory Science from the University of Maryland, Baltimore, and has additionally earned certifications in Quality Assurance and Control.
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