Dionna di Pierro
Director, Small Molecule Cmc Compliance @Vertex Pharmaceuticals
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WORK HISTORY
Director, Small Molecule Cmc Compliance @Vertex Pharmaceuticals
Provides quality oversight for Small Molecule CMC Compliance team and support compliance activities associated with key systems related to CMC Quality, Manufacturing, Distribution and Global Expansion • Provide guidance associated with the establishment, monitoring and advancement of appropriate metrics/KPIs for local Quality Systems • Support the internal audit program, the deployment of the Quality Management System and Regulatory Inspection Readiness and Preparedness • Provides oversight and guidance of the Product Complaint and Recalls/Returns and Defect notification processes • Provides quality oversight of the vendor management program to advance inspection readiness, vendor qualification, performance monitoring, risk management and governance • Provide guidance/oversight of activities associated with compliance as it relates to Annual Product Review, Quality Management Review and Change Control • Provide strategic direction and oversight to the process and mechanisms for local quality system development, including performance monitoring, metric development/maturity and implementation of long-term plans for scalability and sustainability • Support risk management initiatives and ensures risks and quality issues are appropriately identified, escalated and evaluated for impact in addition to monitoring progress of mitigation plans • Support global regulatory inspections (GMP/GDP) and inspection readiness activities • Evaluate new regulatory intelligence and update processes/procedures as necessary
EDUCATION
Davenport University
Bachelors in Business Administration, Business
Kellogg Community College
Graphic Design - Associate of Arts, Graphic Arts - specialized in print media
Davenport University
Masters of Business Administration, Strategic Management
SKILLS
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