Vicente Godoy
Director Global Quality @Miltenyi Biomedicine
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WORK HISTORY
Director Global Quality @Miltenyi Biomedicine
Quality Assurance Leadership: Provide strategic direction for the clinical quality assurance team, setting goals, and ensuring the team\'s performance aligns with the organization\'s mission and values. Build an effective global organization to meet all research and post-approval clinical QA requirements with focus on GCP and GVP- Quality Improvement: Lead efforts to identify areas for improvement in clinical processes, patient care, and quality outcomes. Develop and implement quality improvement initiatives- Auditing and Evaluation: Manage and oversee inspections carried out by Health Authorities and internal functions of clinical processes and quality assurance programs. Implement corrective actions as needed- Risk Management: Develop and maintain risk assessment processes and promote patient safety- Regulatory Compliance: Stay updated on all relevant and emerging healthcare regulations, guidelines, and accreditation standards for global pre-/ post-launch and commercialization activities. Ensure the organization\'s compliance with these requirements- Performance Metrics: Define key performance indicators (KPIs) related to clinical quality. Monitor and report on these metrics to senior management and relevant stakeholders- Training and Development: Develop and deliver training programs for clinical staff to ensure understanding and adherence to quality standards and best practices.
EDUCATION
University of Liverpool
Master of Science, Clinical Research
Faculdade de Ciências Farmacêuticas da USP
University degree, Pharmacy and Biochemistry
SKILLS
ABOUT VICENTE GODOY
Director Global Quality
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