Vincent McDermott
VP of Quality and Regulatory Responsible Person @Shorla Oncology
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WORK HISTORY
VP of Quality and Regulatory Responsible Person @Shorla Oncology
Dublin, IE
Led the Quality Assurance and Regulatory functions at Shorla Oncology, ensuring compliance with HPRA standards. • Served as the Responsible Person for maintaining Wholesale Distribution Authorisation (WDA) and Active Substance Registration (ASR). • Spearheaded New Product Introduction and Launch initiatives, driving strategic support for product development. • Managed departmental budgets effectively to align with company goals and objectives.Lead Auditor for CMO vendor management.
EDUCATION
UCD Professional Academy
Leadership and Management Certificate , Organizational Leadership
Inspired Pharma
GMP Lead Auditor, GMP Auditing
University of Galway
Bachelor of Science (B.Sc.), Chemistry
GMIT
Diploma In Quality Management, Quality Management
Griffith College Dublin
M.Sc Pharmaceutical Business Technology, Pharmaceutical Business Technology
ABOUT VINCENT MCDERMOTT
A seasoned professional with over 20 years of experience in highly regulated pharmaceutical and medical device industries. Currently serving as Vice President of Quality and Regulatory at Shorla Oncology, leveraging expertise in FDA GMP compliance, EU GDP, team leadership for regulatory and QA functions, QMS implementation to advance organizational goals. I am the acting Responsible Person maintaining the Shorla WDA and ASR.A strong technical background from working as an Analytical Services Manager, introduction of packaging lines, NPI and commercial launches. Successfully managed HPRA GDP inspections. New Product Launch and NDA approvals.
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